Dental— FDA advisory panel DE
12,635 FDA 510(k) clearances across 266 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 — UNIQA® Dental Implants System
- EBF — Tetric plus Fill;Tetric plus Flow
- NHA — Neodent Implant System - NeoConvert Fit
- EJT — PROMETAL HN86
- EMA — DIA-CEM
- EIH — Dental Zirconia Blank & Coloring Liquid
- KLE — Any-Etch
- ELW — Dia-X Sil Bite
- EBI — Denture Base Resin V2
- JEY — METICULY Patient-specific CMF solution
- EIA — Midmark Dental Delivery System
- EFB — High speed air turbine handpiece
- LYC — Cytrans Elashield
- EBZ — Curing Light (M-Cure 6)
- LRK — Virtus
Recent clearances in the Dental panel
all clearances- K253206 — METICULY Patient-specific CMF solution
- K261728 — One-Fil LC
- K261046 — Dental Zirconia Blank & Coloring Liquid
- K261166 — DIA-CEM
- K262300 — Denture Base Resin V2
- K253317 — Cytrans Elashield
- K260527 — FACE4D Aligner
- K261129 — OrthoFit
- K261847 — iTero Lumina Pro
- K261147 — Neodent Implant System - NeoConvert Fit
Data sourced from openFDA. This site is unofficial and independent of the FDA.