Dental— FDA advisory panel DE
12,661 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 — ZEROS Dental Implant System
- EBF — Cerasmart Forte
- NHA — Universal Base ASC Engaging +6 more
- EJT — PROMETAL HN86
- EMA — Any-Cem
- EIH — Any-Zircos
- KLE — Any-Etch
- ELW — Dia-X Sil Bite
- EBI — Glidewell Denture Base Resin
- JEY — KLS Martin IPS Oral-Max Implants - MR Conditional +3 more
- EIA — Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)
- EFB — High speed air turbine handpiece
- LYC — Cytrans Elashield
- LRK — Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)
- EBZ — Curing Light (M-Cure 6)
Recent clearances in the Dental panel
all clearances- K262050 — Vioseal X
- K254009 — Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)
- K262202 — Cerasmart Forte
- K261987 — Reusable SmartPeg
- K253909 — NeoPEX Pre-Mixed Obturation Paste
- K262243 — Profisil Free
- K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)
- K253954 — X-Guide Surgical Navigation System
- K261802 — Glidewell Denture Base Resin
- K262104 — Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)
Data sourced from openFDA. This site is unofficial and independent of the FDA.