biotechdentalusa.comAccelx Implant System
Biotech Dental, LLC
Biotech Dental
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010730876 | 3010730876 | Biotech Dental | 1 | Y | 2026-01-01 | 145 Cedar Lane Suite 205 Englewood NJ US 07631 |
| 3014701704 | 3014701704 | Biotech Dental Smilers, SAS | 1 | N | 2026-01-01 | 167 impasse Gaspard Monge Salon-de-Provence Bouches-du-Rhone FR 13300 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 03701045206347 | KONTACT - Protection template for conical abutment | +1(866)277-5662 | info@biotechdentalusa.com |
| 03701045244943 | KONTACT - Marking drill for Atlasurgery system | +1(866)277-5662 | info@biotechdentalusa.com |
| 03701045244974 | KONTACT - Contra angle short shank Ø3.0mm for Atlasurgery system | +1(866)277-5662 | info@biotechdentalusa.com |
| 03701045244981 | KONTACT - Contra angle long shank Ø3.0mm for Atlasurgery system | +1(866)277-5662 | info@biotechdentalusa.com |
| 03701045245018 | KONTACT - Contra angle short shank for Atlasurgery system | +1(866)277-5662 | info@biotechdentalusa.com |
| 03701045245025 | KONTACT - Contra angle long shank for Atlasurgery system | +1(866)277-5662 | info@biotechdentalusa.com |
| 03701045245087 | KONTACT - Empty Multi Kontact Surgical Kit | +1(866)277-5662 | info@biotechdentalusa.com |
| 03701045245100 | KONTACT - Empty prosthesis Kit | +1(866)277-5662 | info@biotechdentalusa.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 300493 | 1972316856 | K213997 | Kontact Dental Implant System | DZE | 2022-07-15 |
| 301597 | 1080411306 | K212961 | SMILERS | NXC | 2021-09-20 |
| 300493 | 1309634400 | K212961 | SMILERS | NXC | 2021-09-20 |
| 300493 | 1178531394 | K210220 | Kontact Dental Implant System | DZE | 2021-06-18 |
| 300493 | 1430098170 | K180924 | Reflect Implant System | DZE | 2019-03-29 |
| 300493 | 1153893481 | ||||
| 300493 | 1249720307 | ||||
| 301597 | 1356172105 | ||||
| 301597 | 1729681893 | ||||
| 300493 | 1786557248 | ||||
| 300493 | 1906263944 | ||||
| 300493 | 2008839297 | ||||
| 301597 | 2022620883 |
Product Codes Associated With Registrations#
PMN#
Kontact Dental Implant System
Biotech Dental, SAS
Biotech Dental Kits
Biotech Dental, SAS
SMILERS
Biotech Dental Smilers, SAS
Kontact Dental Implant System
BIOTECH DENTAL, SAS
GUDID#
KONTACT - Protection template for conical abutment
2022-12-05
KONTACT - Marking drill for Atlasurgery system
2022-12-05
KONTACT - Contra angle short shank Ø3.0mm for Atlasurgery system
2022-12-05
KONTACT - Contra angle long shank Ø3.0mm for Atlasurgery system
2022-12-05
KONTACT - Contra angle short shank for Atlasurgery system
2022-12-05
KONTACT - Contra angle long shank for Atlasurgery system
2022-12-05
KONTACT - Empty Multi Kontact Surgical Kit
2021-12-01
KONTACT - Empty prosthesis Kit
2021-12-01
KONTACT - Empty pick-up impression coping CicaKit
2021-12-02
KONTACT - Empty pop-up impression coping Cica Kit
2021-12-02
KONTACT - Pilot drill empty Kit for guided surgery
2021-12-02
KONTACT - Empty Try-in abutment Kit
2021-12-02
KONTACT - Drill extension
2022-12-05
KONTACT - Atlasurgery mastertube
2022-12-05
KONTACT - Hexagonal prosthesis screwdriver
2022-12-05
KONTACT - Short hexagonal screwdriver for grinding handle
2022-12-05
KONTACT - Long hexagonal screwdriver for grinding handle
2022-12-05
KONTACT - Flathead short screwdriver
2022-12-05
KONTACT - Spacer parallelizer
2022-12-05
KONTACT - Short chuck Ø3.0mm for grinding handle
2022-12-05
KONTACT S - Pre-milled abutment for Ø3 implant for DESS system +K30VP screw
2022-08-04
KONTACT S - Pre-milled abutment for Ø3 implant for MEDENTIKA® system +K30VP screw
2022-08-04
KONTACT S - Pre-milled abutment for Ø3 implant for S3DEL system +K30VP screw
2022-08-04
KONTACT S - Pre-milled abutment for Ø3 implant for YENADENT system +K30VP screw
2022-08-04
KONTACT - PlacementKey for IsoPost
2022-12-05
KONTACT - Manual short shank for Atlasurgery system
2022-12-05
KONTACT - Manual long shank for Atlasurgery system
2022-12-05
KONTACT - Abutment extractor forKey
2022-12-05
KONTACT - Long abutment extractor forKey
2022-12-05
KONTACT - Universal mountdriver for grinding handle
2022-12-05
KONTACT - Short manual chuck
2022-12-05
KONTACT - Long manual chuck
2022-12-05
KONTACT - Extra long implant chuck
2022-12-05
KONTACT S - Pre-milled abutment Ø10mm for DESS system +KVP screw
2022-08-04
KONTACT S - Pre-milled abutment Ø12mm for DESS system +KVP screw
2022-08-04
KONTACT S - Pre-milled abutment Ø14mm for DESS system +KVP screw
2022-08-04
KONTACT S - Pre-milled abutment Ø10mm for MEDENTIKA® system +KVP screw
2022-08-04
KONTACT S - Pre-milled abutment Ø12mm for MEDENTIKA® system +KVP screw
2022-08-04
KONTACT S - Pre-milled abutment Ø14mm for MEDENTIKA® system +KVP screw
2022-08-04
KONTACT S - Pre-milled abutment Ø10mm for S3DEL system +KVP screw
2022-08-04