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
- NB16507SP EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800055794556 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Sutures
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
NB I Fixture by ARUM DENTISTRY Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 ad7fb053-3cd2-49ca-a554-f4a04f2ce85c 33 fields · synced Oct 7, 2026
- EUDAMED a344d0d6-2f01-43fc-83f0-cfe177a9991f 61 fields · synced Jul 11, 2026