Identity
- Trade Name
- BioHorizons FDA UDI
- Generic Name
- Dental osteotome FDA UDI
- Device Name
- Tapered Offset Site Dilator Kit FDA UDI
- Model / Reference
- TODKIT FDA UDI
- Description
- Tapered Offset Site Dilator Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847236001629 FDA UDI
- GMDN Term
- Dental osteotome FDA UDI
Classification
- Commercial Distribution
- Not 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
BioHorizons by Biohorizons Implant Systems Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Biohorizons Implant Systems Inc.
Sources (1)
- FDA UDI 00b2506e-d17a-4e30-a550-070632cc47bb 34 fields · synced May 30, 2026