- [Home](/) › - [FDAPulse](/v/fdapulse) › - [Hubs](/hub/fdapulse) › - Dental # FDA 510(k) clearances and recalls: Dental devices **32 FDA 510(k) clearances and recalls: Dental devices are listed from U.S. FDA openFDA, dated 2026-09-14 to 2026-10-23; the most frequent is Spident Co., Ltd. with 3. Data last updated 2026-11-03; each record links to its official source and a full report.** Data as of 2026-11-03 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA Copy citation Download all 32 FDA 510(k) clearances and recalls: Dental devices (CSV) — $4.99 → Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe [Free sample: 3 records (CSV)](/v1/verticals/fdapulse/records.csv?panel=Dental) 32 records from U.S. FDA openFDA, dated 2026-09-14 to 2026-10-23. Most frequent: Spident Co., Ltd. (3). Each record links to a full report and the official source. Last updated 2026-11-03. Source: U.S. FDA openFDA. **Search, filter and export FDAPulse records** [Run instant live search with these filters](/v/fdapulse?panel=Dental&channel=pseo#vt-out) [Download free 3-row sample CSV](/v1/verticals/fdapulse/records.csv?panel=Dental) Unlock the full CSV for these filters — $4.99 → ✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days ## Get new FDAPulse records by email (free, weekly) We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email. Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe. [See this week's digest](/digest/fdapulse) Records 32 Most frequent - Spident Co., Ltd. (3) - FDC Technology Industry Co. (2) - DiaDent Group International (2) - LuxCreo, Inc. (1) - Guangdong JINME Medical Technology Co., Ltd. (1) ## How do I get new FDA 510(k) clearances and recalls: Dental devices by email? Search, filter and export these records, or get alerts when new ones appear. [Search and filter](/v/fdapulse?panel=Dental) [Watch this exact filter](/v/fdapulse?panel=Dental#more-ways) [See alert plans](/v/fdapulse#pricing) ## What are the top FDA 510(k) clearances and recalls: Dental devices right now? | Record | Specialty | Type | Date | |---|---|---|---| | LuxDesign (K260421): 510(k) cleared for LuxCreo, Inc. | Dental | 510(k) | 2026-10-23 | | Mobile Dental Solution (Model: DS50, DS70, DS90) (K260275): 510(k) cleared for Guangdong JINME Medical Technology Co., Ltd. | Dental | 510(k) | 2026-10-23 | | Forza (K260136): 510(k) cleared for True Function Laboratory, Inc. | Dental | 510(k) | 2026-10-06 | | Wishbone HAE (K260096): 510(k) cleared for Wishbone SA | Dental | 510(k) | 2026-10-09 | | Firstar Dental Handpieces (K260029): 510(k) cleared for FDC Technology Industry Co. | Dental | 510(k) | 2026-10-01 | | Firstar Dental Electric Motor (K260027): 510(k) cleared for FDC Technology Industry Co. | Dental | 510(k) | 2026-10-01 | | REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) (K254210): 510(k) cleared for Hyundai Bioland Co., Ltd. | Dental | 510(k) | 2026-09-25 | | Dia-X Sil Light Body (K254152): 510(k) cleared for DiaDent Group International | Dental | 510(k) | 2026-09-16 | | Dia-X Sil Heavy Body (K254142): 510(k) cleared for DiaDent Group International | Dental | 510(k) | 2026-09-16 | | MultiNeO Dental Implant System (K261295): 510(k) cleared for Alpha Bio Tec , Ltd. | Dental | 510(k) | 2026-10-22 | | BellaTek Bars (K260940): 510(k) cleared for ZimVie US Corp, LLC | Dental | 510(k) | 2026-09-21 | | Yomi S Robotic System (K261321): 510(k) cleared for Neocis, Inc. | Dental | 510(k) | 2026-10-13 | | CMF Titanium Splints (K260913): 510(k) cleared for Materialise NV | Dental | 510(k) | 2026-10-09 | | Elos Accurate Hybrid Base (K261327): 510(k) cleared for Elos Medtech Pinol A/S | Dental | 510(k) | 2026-09-30 | | INNI-CERA (BCM-W500, BCM-W1000) (K262980): 510(k) cleared for DentMedi Co., Ltd. | Dental | 510(k) | 2026-10-21 | | Hand-held Dental X-ray System (HyperLight-M) (K260795): 510(k) cleared for Changzhou Sifary Medical Technology Co., Ltd. | Included in the full CSV with every column 🔒 Unlock all 32 records → | | One Coat Bond; One Coat Bond SL (K263680): 510(k) cleared for Dent4You AG | Included in the full CSV with every column 🔒 Unlock all 32 records → | | EsTemp Implant (K262983): 510(k) cleared for Spident Co., Ltd. | Included in the full CSV with every column 🔒 Unlock all 32 records → | Browse 17 more matching record reports - [Hand-held Dental X-ray System (HyperLight-M) (K260795): 510(k) cleared for Changzhou Sifary Medical Technology Co., Ltd.](/report/fdapulse/hand-held-dental-x-ray-system-hyperlight-m-k260795-cn--k260795) - [One Coat Bond; One Coat Bond SL (K263680): 510(k) cleared for Dent4You AG](/report/fdapulse/one-coat-bond-one-coat-bond-sl-k263680-ch--k263680) - [EsTemp Implant (K262983): 510(k) cleared for Spident Co., Ltd.](/report/fdapulse/estemp-implant-k262983-kr--k262983) - [Core·it Dual (K262982): 510(k) cleared for Spident Co., Ltd.](/report/fdapulse/core-it-dual-k262982-kr--k262982) - [Daybreak Impression Material (K262421): 510(k) cleared for Sleepcare, LLC](/report/fdapulse/daybreak-impression-material-k262421-ca--k262421) - [PDR Airway Device (K262937): 510(k) cleared for Park Dental Research Corp.](/report/fdapulse/pdr-airway-device-k262937-ok--k262937) - [BCS Bioceramic Sealer (K262478): 510(k) cleared for BCS Device Pte., Ltd.](/report/fdapulse/bcs-bioceramic-sealer-k262478-sg--k262478) - [Amber Arte (K262523): 510(k) cleared for Hass Corp.](/report/fdapulse/amber-arte-k262523-kr--k262523) - [OrthoFit Aligner (OrthoFit Aligner A2) (K262433): 510(k) cleared for Spident Co., Ltd.](/report/fdapulse/orthofit-aligner-orthofit-aligner-a2-k262433-kr--k262433) - [Dr.AlignNavi (K262378): 510(k) cleared for InnoDtech, Inc.](/report/fdapulse/dr-alignnavi-k262378-kr--k262378) - [EzSensor HD (K261663): 510(k) cleared for Qpix Solutions, Inc.](/report/fdapulse/ezsensor-hd-k261663-nc--k261663) - [Invisalign System (K262196): 510(k) cleared for Align Technology, Inc.](/report/fdapulse/invisalign-system-k262196-ca--k262196) - [MPa Max adhesive (K262252): 510(k) cleared for Den-Mat Holdings, LLC](/report/fdapulse/mpa-max-adhesive-k262252-ca--k262252) - [Cemented Plus Abutment (K262207): 510(k) cleared for Unidental Co., Ltd.](/report/fdapulse/cemented-plus-abutment-k262207-kr--k262207) - [DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece (K262144): 510(k) cleared for SETAGAYA SEIKI Co., Ltd.](/report/fdapulse/diamed-handpiece-diamed-airmotor-diamed-airmotor-handpiece-jp--k262144) - [TriActive Dental Implant System (K261392): 510(k) cleared for Paragon Implant Mfg., LLC](/report/fdapulse/triactive-dental-implant-system-k261392-ca--k261392) - [ClearClub Impression Material (K261888): 510(k) cleared for ClearClub](/report/fdapulse/clearclub-impression-material-k261888-ca--k261888) [Browse all FDAPulse record reports](/hub/fdapulse/records) ## Which related categories and locations should I check? ### Browse by record type [510(k) clearances (414)](/hub/fdapulse/type/510k-clearances) [Class II device recalls (320)](/hub/fdapulse/type/class-ii-recalls) [Class I device recalls (19)](/hub/fdapulse/type/class-i-recalls) [Class III device recalls (11)](/hub/fdapulse/type/class-iii-recalls) ### Browse by specialty [Radiology (56)](/hub/fdapulse/specialty/radiology) [Orthopedic (53)](/hub/fdapulse/specialty/orthopedic) [Cardiovascular (52)](/hub/fdapulse/specialty/cardiovascular) [General & Plastic Surgery (44)](/hub/fdapulse/specialty/general-plastic-surgery) [Gastroenterology & Urology (27)](/hub/fdapulse/specialty/gastroenterology-urology) [Neurology (23)](/hub/fdapulse/specialty/neurology) [Microbiology (21)](/hub/fdapulse/specialty/microbiology) [Clinical Chemistry (15)](/hub/fdapulse/specialty/clinical-chemistry) [General Hospital (14)](/hub/fdapulse/specialty/general-hospital) [Anesthesiology (12)](/hub/fdapulse/specialty/anesthesiology) [Obstetrics & Gynecology (9)](/hub/fdapulse/specialty/obstetrics-gynecology) [Ophthalmic (7)](/hub/fdapulse/specialty/ophthalmic) ### Browse by record type by specialty [Radiology devices: recent FDA 510(k) clearances (56)](/hub/fdapulse/specialty_type/radiology--510k-clearances) [Orthopedic devices: recent FDA 510(k) clearances (53)](/hub/fdapulse/specialty_type/orthopedic--510k-clearances) [Cardiovascular devices: recent FDA 510(k) clearances (52)](/hub/fdapulse/specialty_type/cardiovascular--510k-clearances) [General & Plastic Surgery devices: recent FDA 510(k) clearances (44)](/hub/fdapulse/specialty_type/general-plastic-surgery--510k-clearances) [Dental devices: recent FDA 510(k) clearances (32)](/hub/fdapulse/specialty_type/dental--510k-clearances) [Gastroenterology & Urology devices: recent FDA 510(k) clearances (27)](/hub/fdapulse/specialty_type/gastroenterology-urology--510k-clearances) [Neurology devices: recent FDA 510(k) clearances (23)](/hub/fdapulse/specialty_type/neurology--510k-clearances) [Microbiology devices: recent FDA 510(k) clearances (21)](/hub/fdapulse/specialty_type/microbiology--510k-clearances) [Clinical Chemistry devices: recent FDA 510(k) clearances (15)](/hub/fdapulse/specialty_type/clinical-chemistry--510k-clearances) [General Hospital devices: recent FDA 510(k) clearances (14)](/hub/fdapulse/specialty_type/general-hospital--510k-clearances) [Anesthesiology devices: recent FDA 510(k) clearances (12)](/hub/fdapulse/specialty_type/anesthesiology--510k-clearances) [Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9)](/hub/fdapulse/specialty_type/obstetrics-gynecology--510k-clearances) [Ophthalmic devices: recent FDA 510(k) clearances (7)](/hub/fdapulse/specialty_type/ophthalmic--510k-clearances) ## Frequently asked questions ### How many FDA 510(k) clearances and recalls: Dental devices are listed? 32 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-23. ### Can I get alerts for Dental? Yes. FDAPulse can email you new records matching this filter; plans are listed on the FDAPulse page. Source: U.S. FDA openFDA. Informational only. [RSS feed of new records](/feed/fdapulse.xml) ## Often used together - [NPIPulse](/v/npipulse) - [EPAPulse](/v/epapulse) - [Municipal Public Works Prime Contract Operating Permit Renewal Pulse](/v/pubworksregrenewpulse) - [TrialRecruitmentPageAudit](/trialrecruitmentpageaudit) - [SubdomainShadowPulse](/subdomainshadowpulse) - [MigrationSignalRadar](/migrationsignalradar) Or get the [Healthcare Vendor Bundle](/v/fdapulse#more-ways) for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.