FDA Review Panel · DE

FDA 510(k) Dental Devices

FDA 510(k) Dental Devices - Regulatory Overview

FDA 510(k) dental devices include instruments, implants and materials used in dental diagnosis and treatment. The FDA review panel code is DE.

Common categories include:

  • Dental implants and prosthetics - crowns, bridges, abutments
  • Dental imaging systems - intraoral X-ray, CBCT, digital sensors
  • Drills and handpieces - turbines, contra-angles, surgical motors
  • Restorative materials - composites, cements, bonding agents
  • Lasers - soft and hard tissue dental lasers

Most dental devices are Class I or Class II. Data sourced from FDA 510(k) public files. Updated monthly.

12611
Total
12602
Cleared
152d
Avg (2y)
1976
Since
9828 Dental devices
5676–5700 of 9828
Cleared Aug 30, 2001
TRANSLUX ENERGY
K012341 · Heraeus Kulzer, Inc.
EBZ · Activator, Ultraviolet, For Polymerization · 37d
Cleared Aug 27, 2001
GPW-SF
K011659 · Gateway Alloys, Inc.
EJT · Alloy, Gold-based Noble Metal · 90d
Cleared Aug 27, 2001
CONCORD 88
K011661 · Gateway Alloys, Inc.
EJT · Alloy, Gold-based Noble Metal · 90d
Cleared Aug 27, 2001
ERIS LAYERING MATERIALS
K012174 · Ivoclar North America, Inc.
EIH · Powder, Porcelain · 46d
Cleared Aug 27, 2001
POINT 4 FLOWABLE
K012321 · Sybron Dental Specialties, Inc.
EBF · Material, Tooth Shade, Resin · 35d
Cleared Aug 23, 2001
STRAUMANN GBR SYSTEM
K011698 · Institut Straumann AG
JEY · Plate, Bone · 83d
Cleared Aug 23, 2001
AVANTE MICRO CRYSTAL SYSTEM
K012231 · Jeneric/Pentron, Inc.
EIH · Powder, Porcelain · 38d
Cleared Aug 23, 2001
LUXACORE/LUXACORE DUAL
K012307 · Dmg USA, Inc.
EBF · Material, Tooth Shade, Resin · 31d
Cleared Aug 23, 2001
PERMACEM / PERMACEM DUAL
K012316 · Dmg USA, Inc.
EMA · Cement, Dental · 31d
Cleared Aug 22, 2001
JEL-20
K012303 · J.F. Jelenko & Co., Inc.
EJS · Alloy, Other Noble Metal · 33d
Cleared Aug 22, 2001
ITI DENTAL IMPLANT SYSTEM
K012757 · Straumann USA
DZE · Implant, Endosseous, Root-form · 5d
Cleared Aug 16, 2001
HELIOSEAL CLEAR CHROMA
K011491 · Ivoclar North America, Inc.
EBC · Sealant, Pit And Fissure, And Conditioner · 93d
Cleared Aug 15, 2001
ALLFIT IMPLANT SYSTEM, SHORT NECK, MODEL STI RT LENGTH, ALLFIT IMPLANT SYSTEM, LONG NECK, MODEL STI RT LN LENGTH
K991822 · Dr. Ihde Dental AG Switzerland
DZE · Implant, Endosseous, Root-form · 811d
Cleared Aug 14, 2001
CORERESTORE 2
K011798 · Sybron Dental Specialties, Inc.
EBF · Material, Tooth Shade, Resin · 67d
Cleared Aug 07, 2001
LACTOSORB RAPIDFLAP
K003281 · Biomet, Inc.
JEY · Plate, Bone · 292d
Cleared Aug 07, 2001
COLLAGEN DENTAL MEMBRANE
K011695 · Collagen Matrix, Inc.
NPL · Barrier, Animal Source, Intraoral · 68d
Cleared Aug 07, 2001
GC E-LIGHT
K012134 · GC America, Inc.
EBZ · Activator, Ultraviolet, For Polymerization · 29d
Cleared Aug 06, 2001
ADD-ON CONDYLE
K002790 · Walter Lorenz Surgical, Inc.
NEI · Prosthesis, Condyle, Mandibular, Temporary · 333d
Cleared Aug 06, 2001
SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25
K981693 · Gebauer Co.
LFD · Saliva, Artificial · 1181d
Cleared Aug 06, 2001
DISPO ETCH
K984380 · Kis Products
KOJ · Airbrush · 972d
Cleared Aug 06, 2001
DISPODRILL
K993124 · Kis Products
KOJ · Airbrush · 686d
Cleared Aug 06, 2001
DISPOPROPHY
K993182 · Kis Products
KOJ · Airbrush · 683d
Cleared Aug 03, 2001
FIRST FILL R.C.S.
K011748 · Jeneric/Pentron, Inc.
KIF · Resin, Root Canal Filling · 58d
Cleared Jul 31, 2001
PREVISION CHEM
K010541 · Heraeus Kulzer, Inc.
EMA · Cement, Dental · 158d
Cleared Jul 31, 2001
BISTITE II DC
K011685 · Tokuyama America, Inc.
EMA · Cement, Dental · 61d

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All categories 9828 DZE Implant, Endosseous, Root-form 1293 EBF Material, Tooth Shade, Resin 804 NHA Abutment, Implant, Dental, Endosseous 695 EJT Alloy, Gold-based Noble Metal 551 EIH Powder, Porcelain 437 EMA Cement, Dental 434 KLE Agent, Tooth Bonding, Resin 383 ELW Material, Impression 324 EBI Resin, Denture, Relining, Repairing, Rebasing 260 JEY Plate, Bone 254 EFB Handpiece, Air-powered, Dental 188 EIA Unit, Operative Dental 186 LRK Device, Anti-snoring 182 LYC Bone Grafting Material, Synthetic 172 EJS Alloy, Other Noble Metal 172