Koncept Innovators, LLC (specification developer, Myrtle Beach, SC): 2 new FDA device listings, incl. device, jaw repositioning

Koncept Innovators, LLC (Myrtle Beach, South Carolina): 2 new FDA device listings, incl. device, jaw repositioning. Its amount of 2 is above the median of 2 (69th percentile). Dated 142 days ago, it serves as a historical benchmark. Score 70/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).

Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)

amount: 2 · 69th percentile of 2,709 DeviceEstablishmentPulse records · 1.0x the median

Free preview: all 14 published fields of this record are shown below. Locked: 15 related SC DeviceEstablishmentPulse records and the 5-column CSV export.

FieldValue
EstablishmentKoncept Innovators, LLC
RoleSpecification developer (outsources manufacturing)
Establishment typesDevelop Specifications But Do Not Manufacture At This Facility
LocationMyrtle Beach, SC, US
New listings2
DevicesDevice, Jaw Repositioning; Device, Anti-Snoring
Product codesLQZ, LRK
Device classesClass II
Medical specialtiesDental
Brand namesDormiva Anti-Snoring Mouth Guard
First new listing2026-06-16
Latest new listing2026-06-16
FDA registration number3010358861
Registration expires2026-12-31
amount percentile69th of 2,709 (median 2, 1.0x median)
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL

  • Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
  • Record date: 2026-06-16
  • Data refreshed: 2026-11-04
  • Refunds on request within 14 days

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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT

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Peer benchmark and outreach value: Koncept Innovators, LLC and 16 South Carolina peers

  • South Carolina DeviceEstablishmentPulse records like this one: 16
  • Koncept Innovators, LLC's amount: 69th percentile of 2,709 records
  • Timing: Low: older than 30 days
  • Estimated pipeline if you contact every South Carolina peer: $3,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)

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70 / 100 Score

  • Brings its own devices to market: buys manufacturing, sterilization and QMS help.
  • Class II or III devices: QMS and regulatory demands.
  • U.S. establishment.

What is the DeviceEstablishmentPulse record for Koncept Innovators, LLC in Myrtle Beach, South Carolina?

Koncept Innovators, LLC (Myrtle Beach, SC), a specification developer (outsources manufacturing), added 2 FDA device listings on 2026-06-16.

How does Koncept Innovators, LLC compare to other South Carolina DeviceEstablishmentPulse records?

Its amount of 2 sits in the upper half (69th percentile) of 2,709 records; the median is 2. It is 142 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.

Koncept Innovators, LLC vs. top 3 peers

OrganizationLocationAmountPercentileRecord date
Koncept Innovators, LLCMyrtle Beach, SC269th2026-06-16
Centinel Spine, LLCWest Chester, PA377th2026-10-22
TORNIER Inc.Columbia City, IN377th2026-10-21
Davol Inc., Sub. C.R. Bard, Inc.Warwick, RI377th2026-10-14

Related records

DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in South Carolina

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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.

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