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 from U.S. FDA openFDA Copy citation

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.

What are the top FDA 510(k) clearances and recalls: Dental devices right now?

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.
• One Coat Bond; One Coat Bond SL (K263680): 510(k) cleared for Dent4You AG
• EsTemp Implant (K262983): 510(k) cleared for Spident Co., Ltd.
• Core·it Dual (K262982): 510(k) cleared for Spident Co., Ltd.
• Daybreak Impression Material (K262421): 510(k) cleared for Sleepcare, LLC
• PDR Airway Device (K262937): 510(k) cleared for Park Dental Research Corp.
• BCS Bioceramic Sealer (K262478): 510(k) cleared for BCS Device Pte., Ltd.
• Amber Arte (K262523): 510(k) cleared for Hass Corp.
• OrthoFit Aligner (OrthoFit Aligner A2) (K262433): 510(k) cleared for Spident Co., Ltd.
• Dr.AlignNavi (K262378): 510(k) cleared for InnoDtech, Inc.
• EzSensor HD (K261663): 510(k) cleared for Qpix Solutions, Inc.
• Invisalign System (K262196): 510(k) cleared for Align Technology, Inc.
• MPa Max adhesive (K262252): 510(k) cleared for Den-Mat Holdings, LLC
• Cemented Plus Abutment (K262207): 510(k) cleared for Unidental Co., Ltd.
• DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece (K262144): 510(k) cleared for SETAGAYA SEIKI Co., Ltd.
• TriActive Dental Implant System (K261392): 510(k) cleared for Paragon Implant Mfg., LLC
• ClearClub Impression Material (K261888): 510(k) cleared for ClearClub

Which related categories and locations should I check?

Browse by record type

510(k) clearances (414) Class II device recalls (320) Class I device recalls (19) Class III device recalls (11)

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Radiology (56) Orthopedic (53) Cardiovascular (52) General & Plastic Surgery (44) Gastroenterology & Urology (27) Neurology (23) Microbiology (21) Clinical Chemistry (15) General Hospital (14) Anesthesiology (12) Obstetrics & Gynecology (9) Ophthalmic (7)

Browse by record type by specialty

Radiology devices: recent FDA 510(k) clearances (56) Orthopedic devices: recent FDA 510(k) clearances (53) Cardiovascular devices: recent FDA 510(k) clearances (52) General & Plastic Surgery devices: recent FDA 510(k) clearances (44) Dental devices: recent FDA 510(k) clearances (32) Gastroenterology & Urology devices: recent FDA 510(k) clearances (27) Neurology devices: recent FDA 510(k) clearances (23) Microbiology devices: recent FDA 510(k) clearances (21) Clinical Chemistry devices: recent FDA 510(k) clearances (15) General Hospital devices: recent FDA 510(k) clearances (14) Anesthesiology devices: recent FDA 510(k) clearances (12) Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9) Ophthalmic devices: recent FDA 510(k) clearances (7)

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

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