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SCREW-LINE Single patient form drill
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref J5060.4316Ref J5060.5011Ref J5060.3316Ref J5060.3309Ref J5060.5016Ref J5060.3816Ref J5060.5009Ref J5060.3809Ref J5060.4311Ref J5060.3311Ref J4012.1620
by ALTATEC GmbH
Identity
- Trade Name
- SCREW-LINE Single patient form drill EUDAMEDScrew EUDAMEDScrew for bar abutment FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- CAMLOG® SP Drill SCREW-LINE EUDAMEDScrew, for bar abutment EUDAMEDScrew, 20 mm, for bar abutment M1.6 L 20.0 mm FDA UDI
- Model / Reference
- J5060.4316 EUDAMEDJ5060.5011 EUDAMEDJ5060.3316 EUDAMEDJ5060.3309 EUDAMEDJ5060.5016 EUDAMEDJ5060.3816 EUDAMEDJ5060.5009 EUDAMEDJ5060.3809 EUDAMEDJ5060.4311 EUDAMEDJ5060.3311 EUDAMEDJ4012.1620 EUDAMEDFDA UDI
- Description
- Screw, 20 mm, for bar abutment M1.6 L 20.0 mm FDA UDI
Identifiers
- Catalog Number
- J4012.1620 FDA UDI
- Primary DI / UDI-DI
- 04099797012293 EUDAMED04099797012323 EUDAMED04099797012194 EUDAMED04099797012163 EUDAMED04099797012347 EUDAMED04099797012248 EUDAMED04099797012316 EUDAMED04099797012217 EUDAMED04099797012279 EUDAMED04099797012170 EUDAMED04099797004328 EUDAMEDE219J401216201 FDA UDI
- Basic UDI-DI
- 40997970004015000000000GM EUDAMED40997970006008000000000LX EUDAMED
- Secondary DI
- E219J506043161 EUDAMEDE219J506050111 EUDAMEDE219J506033161 EUDAMEDE219J506033091 EUDAMEDE219J506050161 EUDAMEDE219J506038161 EUDAMEDE219J506050091 EUDAMEDE219J506038091 EUDAMEDE219J506043111 EUDAMEDE219J506033111 EUDAMEDE219J401216201 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- Z12110102 DENTAL DRILLS EUDAMEDP01020180 DENTAL IMPLANTS - ACCESSORIES EUDAMED
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDFDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
SCREW-LINE Single patient form drill by ALTATEC GmbH — 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 | 40997970004015000000000GM | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
- EUDAMED SRN
- DE-MF-000006230
Sources (12)
- EUDAMED 80da1cc0-b2a2-4025-bf4d-e4b3ffdf3abd 61 fields · synced Aug 3, 2026
- EUDAMED 32c05da4-5d58-4e69-abf6-ea0d087d5b48 61 fields · synced May 16, 2026
- EUDAMED 49993e28-2531-4c44-aa2e-e42400839e25 61 fields · synced May 16, 2026
- EUDAMED 8cb503fc-c448-4ee6-8346-6bfa67180280 61 fields · synced May 17, 2026
- EUDAMED 72bfb4fd-b5b6-488f-bfa3-e303ac149a0f 61 fields · synced May 17, 2026
- EUDAMED eb2da41a-6e6b-4116-8049-5d6d6dd3379e 61 fields · synced May 17, 2026
- EUDAMED 01aed33c-6be4-4cc8-b0bb-9535263813d0 61 fields · synced May 17, 2026
- EUDAMED 114a0667-2e55-471a-bc18-951b7122af70 61 fields · synced May 17, 2026
- EUDAMED de5267c9-9bcc-4d4e-a9c3-da692e62a2bb 61 fields · synced May 18, 2026
- EUDAMED e0295afd-dfed-467f-875c-f0dcb3e8f796 61 fields · synced May 18, 2026
- FDA UDI bde0c4ce-4020-41a9-8296-13fb445d4cc2 35 fields · synced May 30, 2026
- EUDAMED 28efbdca-1494-4255-8d6a-844c7569ac04 61 fields · synced Jul 16, 2026