FDA 510(k) Dental Devices
About Dental Devices
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.
12535
Total
12526
Cleared
127d
Avg days
1976
Since
793 Dental devices
Cleared
Dec 08, 2023
BTI Interna Prosthetic Components
NHA
Abutment, Implant, Dental, Endosseous
91d
Cleared
Dec 07, 2023
ARi ExCon Implant System
DZE
Implant, Endosseous, Root-form
157d
Cleared
Dec 07, 2023
S.I.N. Dental Implant System
DZE
Implant, Endosseous, Root-form
231d
Cleared
Dec 05, 2023
SS Abutment System
NHA
Abutment, Implant, Dental, Endosseous
132d
Cleared
Dec 01, 2023
Single Platform SP1 Implant System
DZE
Implant, Endosseous, Root-form
112d
Cleared
Dec 01, 2023
AlignerFlow LC
DYH
Adhesive, Bracket And Tooth Conditioner, Resin
163d
Cleared
Nov 21, 2023
Meta G UCLA Abutment
NHA
Abutment, Implant, Dental, Endosseous
90d
Cleared
Nov 14, 2023
Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG)
LRK
Device, Anti-snoring
32d
Cleared
Nov 14, 2023
Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems
NHA
Abutment, Implant, Dental, Endosseous
210d
Cleared
Oct 31, 2023
Neodent Implant System - GM Zygomatic Implant System
DZE
Implant, Endosseous, Root-form
110d
Cleared
Oct 30, 2023
AOT & T-L Abutment
NHA
Abutment, Implant, Dental, Endosseous
126d
Cleared
Oct 27, 2023
Centrix FluoroSilver Silver Diamine Fluoride 38%
PHR
Diammine Silver Fluoride Dental Hypersensitivity Varnish
438d
Cleared
Oct 20, 2023
Lucitone Digital Print Denture System
EBI
Resin, Denture, Relining, Repairing, Rebasing
142d
Cleared
Oct 18, 2023
INNO SLA Submerged Narrow Implant System
DZE
Implant, Endosseous, Root-form
156d
Cleared
Oct 18, 2023
Byte Aligner System
NXC
Aligner, Sequential
266d
Cleared
Oct 16, 2023
Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL
DZE
Implant, Endosseous, Root-form
276d
Cleared
Oct 13, 2023
MRI compatibility for existing BioHorizons dental implants and abutments
DZE
Implant, Endosseous, Root-form
308d
Cleared
Oct 11, 2023
MegaGen Dental Implant Systems Portfolio - MR Conditional
DZE
Implant, Endosseous, Root-form
219d
Cleared
Oct 05, 2023
OsteoCentric Dental Implant System
DZE
Implant, Endosseous, Root-form
248d
Cleared
Sep 29, 2023
CeraPutty
KIF
Resin, Root Canal Filling
59d
Cleared
Sep 28, 2023
BeautiLink SA
EMA
Cement, Dental
1d
Cleared
Sep 26, 2023
Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
NXC
Aligner, Sequential
61d
Cleared
Sep 26, 2023
Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems
NHA
Abutment, Implant, Dental, Endosseous
309d
Cleared
Sep 23, 2023
Osstem Implant System
DZE
Implant, Endosseous, Root-form
374d
Cleared
Sep 15, 2023
BTI Dental Implant System UnicCa® – Aesthetic Post Abutments
NHA
Abutment, Implant, Dental, Endosseous
86d
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