Identity
- Trade Name
- Tool set for individual screw FDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Tool set for individual screw connections M 1.4 10 Parts 1 Assortment FDA UDI
- Model / Reference
- 33000600 FDA UDI
- Description
- Tool set for individual screw connections M 1.4 10 Parts 1 Assortment FDA UDI
Identifiers
- Catalog Number
- 33000600 FDA UDI
- Primary DI / UDI-DI
- EBRE330006000 FDA UDI
- FDA Product Code
- DZA FDA UDI
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4130 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Screw endosteal dental implant, two-piece
Tool set for individual screw by bredent GmbH & Co. KG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Screw endosteal dental implant, two-piece.
- ET III NH Ultra-Wide Fixture No-Mount — HIOSSEN INC. · Class II
- SNUCONE BONE LEVEL IMPLANT SYSTEM — SNUCONE Co., LTD. · Class II
- LW Solid Abutment — Ossvis Co., Ltd. · Class II
- LW Vis Abutment — Ossvis Co., Ltd. · Class II
- s-Clean TiN Half Coating Angled Abutment — DENTIS CO. , LTD · Class II
- ET II Fixture SA Mini No-Mounted — HIOSSEN INC. · Class II
- LW Vis Abutment — Ossvis Co., Ltd. · Class II
- PRAMA RF WHITE IMPLANT ZIRTI — SWEDEN & MARTINA INC · 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
- bredent GmbH & Co. KG
Sources (1)
- FDA UDI 92bd35c8-9a76-4750-92ae-d23be4c8bb20 35 fields · synced May 30, 2026