Identity
- Trade Name
- NB I Fixture EUDAMEDFDA UDI
- Generic Name
- Screw endosteal dental implant, two-piece FDA UDI
- Device Name
- Dental Implant Fixture EUDAMED
- Model / Reference
- NB14508SP EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800055794334 EUDAMEDFDA UDI
- Basic UDI-DI
- 88000557FIXXG EUDAMED
- 510(k) Number
- K213506 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, two-piece FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
Sutures
Yes
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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Screw endosteal dental implant, two-piece
NB I Fixture by ARUM DENTISTRY Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Screw endosteal dental implant, two-piece.
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Cleared under the same submission
K213506 also covers:
- ARUM NB 1 SA Fixture — ARUM DENTISTRY Co., Ltd.
- ARUM NB 1 SA Fixture — ARUM DENTISTRY Co., Ltd.
- ARUM NB 1 SA Fixture — ARUM DENTISTRY Co., Ltd.
- ARUM NB 1 SA Fixture — ARUM DENTISTRY Co., Ltd.
- ARUM NB 1 SA Fixture — ARUM DENTISTRY Co., Ltd.
- ARUM NB 1 SA Fixture — ARUM DENTISTRY Co., Ltd.
- ARUM NB 1 SA Fixture — ARUM DENTISTRY Co., Ltd.
- ARUM NB 1 SA Fixture — ARUM DENTISTRY Co., Ltd.
- ARUM NB 1 SA Fixture — ARUM DENTISTRY Co., Ltd.
- ARUM NB 1 SA Fixture — ARUM DENTISTRY Co., Ltd.
- ARUM NB 1 SA Fixture — ARUM DENTISTRY Co., Ltd.
- ARUM NB 1 SA Fixture — ARUM DENTISTRY Co., Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- ARUM DENTISTRY Co., Ltd.
Sources (2)
- FDA UDI c0b6c548-3199-4224-84b6-2a72707ca94c 33 fields · synced Oct 5, 2026
- EUDAMED 6ff2e522-4d67-48a2-b49d-4d3d80ed7029 61 fields · synced Oct 5, 2026