BioHorizons
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- BioHorizons EUDAMEDFDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Surgical Drills (Non-Sterile) EUDAMEDTapered Short Soft Bone Drill, 3.2/4.2mm FDA UDI
- Model / Reference
- TDS42SB EUDAMEDFDA UDIBioHorizons Dental Instruments EUDAMED
- Description
- Tapered Short Soft Bone Drill, 3.2/4.2mm FDA UDI
Identifiers
- Catalog Number
- TDS42SB FDA UDI
- Primary DI / UDI-DI
- 00847236026172 EUDAMEDFDA UDI
- Basic UDI-DI
- 08472360IIAINST002Q5 EUDAMED
- Direct Marketing DI
- 00847236025946 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
Yes
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Fixture/appliance dental drill bit, reusable
BioHorizons by Biohorizons Implant Systems Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Fixture/appliance dental drill bit, reusable.
- Hahn — PRISMATIK DENTALCRAFT, INC. · Class I
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A. · Class I
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- Prima Plus — Keystone Dental Inc. · Class I
- FTN Tapered Drill — DIO Corporation · Class I
- Prima — Keystone Dental Inc. · Class I
- Twist Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Stopper Drill — Megagen Implant Co. Ltd · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Biohorizons Implant Systems Inc.
Sources (2)
- FDA UDI 82fe6ec5-9fc8-47a5-bde6-ef120fc595f8 34 fields · synced Jul 22, 2026
- EUDAMED dcb76e82-2a04-400e-bcb7-e2c2fed5fa0a 61 fields · synced Jul 22, 2026