← Back to catalogue
Anew Surgical and Prosthetic Instrumentation Kit
FDA UDIClass I (US FDA UDI)
by Dentatus AB
Identity
- Trade Name
- Anew Surgical and Prosthetic Instrumentation Kit FDA UDI
- Generic Name
- Dental implant suprastructure kit FDA UDI
- Device Name
- ANEW Surgical and Prosthetic Instrumentation Kit - Drill System 2 2 - 1.4 Center Point Pilot Drills (1 Short & 1 Long) (=1.8 Impl. Diam.) - Drill System 2 2 - CePo Drills for 2.2 and 2.4 Implants 1 - Manual Adaptor for R/A Driver 1 - Anew Chisel-End Screwcap Driver 1 - R/A Hpc Driver 1 - Trephine Hollow Drill 1 - Sterilizable Instrumentation Kit Box 1 - Instruction for use 1 - X-ray template 5 - Moisture Absorbing Papers FDA UDI
- Model / Reference
- SK-3 FDA UDI
- Description
- ANEW Surgical and Prosthetic Instrumentation Kit - Drill System 2 2 - 1.4 Center Point Pilot Drills (1 Short & 1 Long) (=1.8 Impl. Diam.) - Drill System 2 2 - CePo Drills for 2.2 and 2.4 Implants 1 - Manual Adaptor for R/A Driver 1 - Anew Chisel-End Screwcap Driver 1 - R/A Hpc Driver 1 - Trephine Hollow Drill 1 - Sterilizable Instrumentation Kit Box 1 - Instruction for use 1 - X-ray template 5 - Moisture Absorbing Papers FDA UDI
Identifiers
- Catalog Number
- SK-3 FDA UDI
- Primary DI / UDI-DI
- 07350081494858 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant suprastructure kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental implant suprastructure kit
Anew Surgical and Prosthetic Instrumentation Kit by Dentatus AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure kit.
- KLOCKNER — SOADCO, S.L. · Class I
- KLOCKNER — SOADCO, S.L. · Class II
- ZERAMEX® SB Abutment Angular 15°, 1mm (incl. Screw) — CeramTec Schweiz GmbH · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- CERALOG® PL Abutment 15° angled, Ø 3.8 mm, GH 1.0 mm — CeramTec Schweiz GmbH · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- Prosthetic Accessories — A.B. DENTAL DEVICES LTD · Class II
- KLOCKNER — SOADCO, S.L. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentatus AB
Sources (1)
- FDA UDI 75e51766-50a9-44ec-8ab0-5d429607f6aa 35 fields · synced Jun 6, 2026