Identity
- Trade Name
- Neodent FDA UDI
- Generic Name
- Screw endosteal dental implant, one-piece FDA UDI
- Device Name
- HELIX SHORT IMPLANT EUDAMEDFDA UDI
- Model / Reference
- 109.1066 EUDAMEDFDA UDIIMPLANT EUDAMED
- Description
- HELIX SHORT IMPLANT FDA UDI
Identifiers
- Catalog Number
- 109.1066 FDA UDI
- Primary DI / UDI-DI
- 07899878057291 EUDAMEDFDA UDI
- Basic UDI-DI
- 987800101V6 EUDAMED
- 510(k) Number
- K223638 FDA UDI
- FDA Product Code
- DZE FDA UDI
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
- GMDN Term
- Screw endosteal dental implant, one-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
Yes
Expiration Date
Yes
Manufacturing Date
Yes
Dimensions & Sizes
- Size
- Length — 4.0 Millimeter FDA UDILumen/Inner Diameter — 4.0 Millimeter FDA UDI
Category: Screw endosteal dental implant, one-piece
Neodent by JJGC Indústria e Comércio de Materiais Dentários S/A. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Screw endosteal dental implant, one-piece.
- Infinity External Hex System — ACE SURGICAL SUPPLY CO., INC. · Class II
- KJ Mini Implant System — Kj Meditech · Class II
- VERSALIS S PLUS — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
- Zirlux — HENRY SCHEIN, INC. · Class II
- KLOCKNER — SOADCO, S.L. · Class II
- Tryon — S.I.N. - Sistema DE Implante Nacional S.A. · Class II
- KJ Mini Implant System — Kj Meditech · Class II
- Advanced Intermezzo Fixture — Megagen Implant Co. Ltd · Class II
Cleared under the same submission
K223638 also covers:
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A.
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A.
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A.
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A.
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A.
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A.
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A.
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A.
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A.
- Neodent — JJGC Indústria e Comércio de Materiais Dentários S/A.
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
Sources (2)
- FDA UDI 3f2c7796-bf7b-48f3-bf2b-20ee473a99bc 37 fields · synced Oct 9, 2026
- EUDAMED b685532e-029e-42ca-a252-6c75c605a878 61 fields · synced Oct 8, 2026