Identity
- Trade Name
- BioHorizons FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, single-use FDA UDI
- Device Name
- Tapered HD Drill, 5.4mm, Single Use FDA UDI
- Model / Reference
- TSD2054HDSU FDA UDI
- Description
- Tapered HD Drill, 5.4mm, Single Use FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847236011840 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Fixture/appliance dental drill bit, single-use 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fixture/appliance dental drill bit, single-use
BioHorizons by Biohorizons Implant Systems Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fixture/appliance dental drill bit, single-use.
- IQ Dental — IQ DENTAL SUPPLY LLC · Class I
- Screw Removal Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Driva™ Gold Series Drills — BIOMET 3I, LLC · Class I
- Trefoil™ — Nobel Biocare AG · Class I
- ELEMENT profile drill — Thommen Medical AG · Class I
- Gates Glidden Drills — TULSA DENTAL PRODUCTS LLC · Class I
- Screw Removal Drill — OSSTEM IMPLANT Co., Ltd. · Class I
- Driva™ Gold Series Drills — BIOMET 3I, LLC · Class I
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
- Biohorizons Implant Systems Inc.
Sources (1)
- FDA UDI 91507599-3456-4158-b1de-823abb3c8df8 33 fields · synced May 31, 2026