Dental— FDA advisory panel DE
12,699 FDA 510(k) clearances across 267 product codes since 1976.
By Andrew Weston — Installation Systems Engineer
The dental panel spans the full dental workflow: endosseous implants and abutments, restorative materials (composites, cements, bonding agents), impression materials and their digital replacements (intraoral scanners), orthodontic brackets and aligners, handpieces, curing lights, and dental X-ray equipment. Clear-aligner systems are a notable modern current — the sequenced-aligner product family clears through this panel and its filings track a highly competitive consumer market.
Dental implants are the panel's regulatory anchor: root-form endosseous implants are Class II with well-established special controls, which keeps a steady stream of implant-system clearances flowing from both global majors and regional manufacturers. Because dental devices skew toward materials science, the 510(k) summaries here lean heavily on bench performance data — worth remembering when you evaluate how much a "substantially equivalent" claim actually tells you about clinical behavior.
Clearances per year
last 10 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
Top product codes in the Dental panel
all codes- DZE — MultiNeO Dental Implant System
- EBF — Core·it Dual
- NHA — Elos Accurate Hybrid Base
- EJT — PROMETAL HN86
- EMA — EsTemp Implant
- EIH — Zirconia Collective 4Y Dental Zirconia Blank
- KLE — One Coat Bond; One Coat Bond SL
- ELW — Dia-X Sil Light Body
- EBI — Glidewell Denture Base Resin
- JEY — KLS Martin IPS Oral-Max Implants - MR Conditional +3 more
- EIA — Mobile Dental Solution (Model: DS50, DS70, DS90)
- EFB — Firstar Dental Handpieces
- LYC — Cytrans Elashield
- LRK — PDR Airway Device
- EBZ — Curing Light (M-Cure 6)
Recent clearances in the Dental panel
all clearances- K262685 — Zirconia Collective 4Y Dental Zirconia Blank
- K263860 — Shining3D Clear Aligner System
- K260356 — EndoColibri
- K262415 — OSSIX Plus
- K262756 — Zirconia Dental Ceramics and Staining Solution
- K262775 — AquaVance Clear Fluoride Treatment
- K260275 — Mobile Dental Solution (Model: DS50, DS70, DS90)
- K260421 — LuxDesign
- K261295 — MultiNeO Dental Implant System
- K262980 — INNI-CERA (BCM-W500, BCM-W1000)
Data sourced from openFDA. This site is unofficial and independent of the FDA.