Dental FDA 510(k) clearances, last 90 days
US companies with an FDA 510(k) clearance in Dental from Aug 2, 2026 to Oct 30, 2026. FDA data through October 30, 2026.
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Last 90 days
20 clearances in the last 90 days. The same 90 days a year earlier: 28.
For contract manufacturers and test labs
Dental accounts for 20 US 510(k) clearances in the last 90 days. The product code with the most clearances in this window is LRK (Device, Anti-Snoring). Contract manufacturers and test labs that work on Dental devices can read the company, the device and the date below, then open the FDA record. Contacts for these companies come with a free month.
Top product codes
| Product code | Device type | Clearances |
|---|---|---|
LRK | Device, Anti-Snoring | 2 |
PNN | Orthodontic Software | 2 |
QRY | Dental Navigation System | 2 |
SHI | Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter | 2 |
DZE | Implant, Endosseous, Root-Form | 1 |
| Decision date | Company | Device | FDA record |
|---|---|---|---|
| Oct 30, 2026 | Zirconia Collective, Inc. | Zirconia Collective 4Y Dental Zirconia Blank | K262685 |
| Oct 27, 2026 | The Belport Company Inc., DBA Gingi-Pak | AquaVance Clear Fluoride Treatment | K262775 |
| Oct 23, 2026 | LuxCreo, Inc. | LuxDesign | K260421 |
| Oct 20, 2026 | Park Dental Research Corp. | PDR Airway Device | K262937 |
| Oct 20, 2026 | Sleepcare, LLC | Daybreak Impression Material | K262421 |
| Oct 13, 2026 | Neocis, Inc. | Yomi S Robotic System | K261321 |
| Oct 6, 2026 | True Function Laboratory, Inc. | Forza | K260136 |
| Sep 30, 2026 | Qpix Solutions, Inc. | EzSensor HD | K261663 |
| Sep 25, 2026 | Align Technology, Inc. | Invisalign System | K262196 |
| Sep 24, 2026 | Den-Mat Holdings, LLC | MPa Max adhesive | K262252 |
| Sep 21, 2026 | ZimVie US Corp, LLC | BellaTek Bars | K260940 |
| Sep 17, 2026 | Paragon Implant Mfg., LLC | TriActive Dental Implant System | K261392 |
| Sep 16, 2026 | ClearClub | ClearClub Impression Material | K261888 |
| Sep 10, 2026 | GC America, Inc. | Cerasmart Forte | K262202 |
| Sep 4, 2026 | NuSmile, Ltd. | NeoPEX Pre-Mixed Obturation Paste | K253909 |
| Aug 28, 2026 | X-Nav Technologies, LLC | X-Guide Surgical Navigation System | K253954 |
| Aug 27, 2026 | Prismatik Dentalcraft, Inc. | Glidewell Denture Base Resin | K261802 |
| Aug 25, 2026 | Achaemenid, LLC | iNOS intraoral biosensor | K254304 |
| Aug 17, 2026 | KLS-Martin L.P. | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions | K260137 |
| Aug 7, 2026 | The Belport Company Inc., DBA Gingi-Pak | PacTemp Automix NE | K261937 |
- Oct 30, 2026Zirconia Collective, Inc.
Zirconia Collective 4Y Dental Zirconia Blank
- Oct 27, 2026The Belport Company Inc., DBA Gingi-Pak
AquaVance Clear Fluoride Treatment
- Oct 23, 2026LuxCreo, Inc.
LuxDesign
- Oct 20, 2026Park Dental Research Corp.
PDR Airway Device
- Oct 20, 2026Sleepcare, LLC
Daybreak Impression Material
- Oct 13, 2026Neocis, Inc.
Yomi S Robotic System
- Oct 6, 2026True Function Laboratory, Inc.
Forza
- Sep 30, 2026Qpix Solutions, Inc.
EzSensor HD
- Sep 25, 2026Align Technology, Inc.
Invisalign System
- Sep 24, 2026Den-Mat Holdings, LLC
MPa Max adhesive
- Sep 21, 2026ZimVie US Corp, LLC
BellaTek Bars
- Sep 17, 2026Paragon Implant Mfg., LLC
TriActive Dental Implant System
- Sep 16, 2026ClearClub
ClearClub Impression Material
- Sep 10, 2026GC America, Inc.
Cerasmart Forte
- Sep 4, 2026NuSmile, Ltd.
NeoPEX Pre-Mixed Obturation Paste
- Aug 28, 2026X-Nav Technologies, LLC
X-Guide Surgical Navigation System
- Aug 27, 2026Prismatik Dentalcraft, Inc.
Glidewell Denture Base Resin
- Aug 25, 2026Achaemenid, LLC
iNOS intraoral biosensor
- Aug 17, 2026KLS-Martin L.P.
KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions
- Aug 7, 2026The Belport Company Inc., DBA Gingi-Pak
PacTemp Automix NE
Source: FDA public records. The K number is in Whimbrel's corpus, and the company, device, state, product code and review panel are the openFDA 510(k) fields for that K number. FDA data through October 30, 2026. Each K number links to the FDA record. openFDA data are not validated by the FDA for medical decisions. Check the FDA record before you rely on a row. openFDA 510(k) API. FDA 510(k) database.
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