Identity
- Trade Name
- SICAT Bite Plate EUDAMEDFDA UDI
- Generic Name
- Surgical drill guide, single-use FDA UDI
- Device Name
- SICAT Bite Plate EUDAMEDFDA UDI
- Model / Reference
- V1.0 EUDAMED10300 EUDAMED10300100 FDA UDI
- Description
- SICAT Bite Plate FDA UDI
Identifiers
- Catalog Number
- 10300100 FDA UDI
- Primary DI / UDI-DI
- D776SBPV100 EUDAMEDFDA UDI
- Basic UDI-DI
- ++D776BITEPLATEKB EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Q010399 SURGICAL DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Surgical drill guide, 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
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
No
FDA UDI
SICAT Bite Plate by SICAT GmbH & Co. KG — 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 | ++D776BITEPLATEKB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- SICAT GmbH & Co. KG
- EUDAMED SRN
- DE-MF-000005604
Sources (2)
- EUDAMED a31f3090-1267-4f6d-a915-7da7477ea887 61 fields · synced Jul 29, 2026
- FDA UDI b49b7d68-1012-4507-8801-600b8b6310a1 35 fields · synced May 30, 2026