BioHorizons
FDA UDIEUDAMEDClass I (US FDA UDI)
Identity
- Trade Name
- BioHorizons EUDAMEDFDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Sleeves EUDAMEDEasy Ti Temp Abutment Pick-up Sleeve (pack of 3) FDA UDI
- Model / Reference
- PXETPS EUDAMEDFDA UDIBioHorizons Dental Instruments EUDAMED
- Description
- Easy Ti Temp Abutment Pick-up Sleeve (pack of 3) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00847236011345 EUDAMEDFDA UDI
- Basic UDI-DI
- 08472360IINST010UF EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA 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
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
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: Dental implant suprastructure, temporary, preformed, single-use
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 Dental implant suprastructure, temporary, preformed, single-use.
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- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY 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 202e9035-ef70-4a5f-b01d-1b07c8a38306 33 fields · synced Jul 9, 2026
- EUDAMED cbd568f1-a9a4-4fe6-8c6a-e38e457aec5d 61 fields · synced Jul 9, 2026