Identity
- Trade Name
- BioHorizons FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Conical Temporary Abutment, Engaging, Regular FDA UDI
- Model / Reference
- CRTEA FDA UDI
- Description
- Conical Temporary Abutment, Engaging, Regular FDA UDI
Identifiers
- Catalog Number
- CRTEA FDA UDI
- Primary DI / UDI-DI
- 00847236025489 FDA UDI
- 510(k) Number
- K240187 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
No
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
MR Conditional FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
BioHorizons by Biohorizons Implant Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Cleared under the same submission
K240187 also covers:
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
- BioHorizons — BIOHORIZONS IMPLANT SYSTEMS INC.
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Biohorizons Implant Systems Inc.
Sources (1)
- FDA UDI 6f6df4e7-ce33-4447-86a8-969ace7fc65e 35 fields · synced Jun 1, 2026