Identity
- Trade Name
- Screw Tap Tapered NP EUDAMEDScrew Tap Tapered NP Single-Patient Use EUDAMEDNobel Biocare® FDA UDI
- Generic Name
- Bone tap, single-use FDA UDI
- Device Name
- Reusable drills for osteotomy EUDAMEDDrills for osteotomy EUDAMEDScrew Tap Tapered NP Single-Patient Use FDA UDI
- Model / Reference
- 36717 EUDAMED37050 EUDAMEDFDA UDI
- Description
- Screw Tap Tapered NP Single-Patient Use FDA UDI
Identifiers
- Catalog Number
- 37050 FDA UDI
- Primary DI / UDI-DI
- 07332747211047 EUDAMED07332747190496 EUDAMEDFDA UDI
- Basic UDI-DI
- 73327470000001226R EUDAMED73327470000001206M EUDAMED
- Direct Marketing DI
- 07332747034158 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMEDQ010501 DENTAL BURS AND ABRASIVE DISKS, SINGLE-USE EUDAMED
- GMDN Term
- Bone tap, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDEUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMEDEUDAMED
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
Screw Tap Tapered NP by Nobel Biocare AB — Class IIa — 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 | 73327470000001226R | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nobel Biocare AB
- EUDAMED SRN
- SE-MF-000000009
Sources (3)
- EUDAMED 925ced93-c2da-4ad5-a7c1-506edcc40121 61 fields · synced Jul 28, 2026
- EUDAMED c802690a-d13b-4a27-b8d1-6fbe5712c8e6 61 fields · synced May 17, 2026
- FDA UDI af1567d5-4d1d-4a55-a5a0-fb0670da542e 36 fields · synced May 30, 2026