Identity
- Trade Name
- SURGICAL GUIDE SLEEVE BTI FDA UDI
- Generic Name
- Dental implantation drilling template guide-sleeve FDA UDI
- Device Name
- SINGLE-USE GUIDING INSTRUMENTS EUDAMED
- Model / Reference
- SCG EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08435389827559 EUDAMEDFDA UDI
- Basic UDI-DI
- 84353898SINGLE-GUIDEFG EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Dental implantation drilling template guide-sleeve FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Spain EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Moist Heat or Steam Sterilization FDA UDI
Single-Use Guiding Instruments by B.t.i. Biotechnology Institute, S.l — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 84353898SINGLE-GUIDEFG | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- B.t.i. Biotechnology Institute, S.l
- EUDAMED SRN
- ES-MF-000001701
Sources (2)
- EUDAMED 1b152a8f-c661-4300-af75-667e6a429687 61 fields · synced Aug 1, 2026
- FDA UDI d32d67f4-ee57-45a9-9927-ba591dc3e682 32 fields · synced May 30, 2026