Identity
- Trade Name
- IS-III active Fixture EUDAMEDNeobiotech Implant System FDA UDI
- Generic Name
- Dental implant system FDA UDI
- Device Name
- Ø4.5*11.5mm FDA UDI
- Model / Reference
- IS34511AP EUDAMEDFDA UDI
- Description
- Ø4.5*11.5mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809486293652 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809486293652 EUDAMED
- 510(k) Number
- K181138 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Dental implant system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Market of Registration
- Poland 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dental implant system
Neobiotech Implant System by Neobiotech. co., ltd — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant system.
- Healing abutment Regular — BIO CONCEPT Co., Ltd. · Class II
- Ball Attachment 5 mm — NOGA MEDICAL PRODUCTS LTD · Class II
- Equator Abutment, Φ 6.5mm, GH 2mm — BIO CONCEPT Co., Ltd. · Class II
- Short Abutment — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Magicore — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Magicore S — InnoBioSurg Co., Ltd(IBS implant Co., Ltd) · Class II
- Implant Regular — BIO CONCEPT Co., Ltd. · Class II
- TRI — Tri Dental Implants Int. AG · Class II
Cleared under the same submission
K181138 also covers:
- Neobiotech Implant System — Neobiotech. co., ltd
- Neobiotech Implant System — Neobiotech. co., ltd
- Neobiotech Implant System — Neobiotech. co., ltd
- Neobiotech Implant System — Neobiotech. co., ltd
- Neobiotech Implant System — Neobiotech. co., ltd
- Neobiotech Implant System — Neobiotech. co., ltd
- Neobiotech Implant System — Neobiotech. co., ltd
- Neobiotech Implant System — Neobiotech. co., ltd
- Neobiotech Implant System — Neobiotech. co., ltd
- Neobiotech Implant System — Neobiotech. co., ltd
- Neobiotech Implant System — Neobiotech. co., ltd
- Neobiotech Implant System — Neobiotech. co., ltd
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Neobiotech. co., ltd
Sources (2)
- FDA UDI 031fb98a-4e78-43cb-ac3c-072a2fe9535f 34 fields · synced Jun 14, 2026
- EUDAMED 24334c90-43e7-469a-9e4e-a35dfa288790 61 fields · synced Jun 11, 2026