Identity
- Trade Name
- Neodent FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Complete Surgical Kits EUDAMEDCOMPLETE GM TRY-IN KIT FDA UDI
- Model / Reference
- 110.305 EUDAMEDFDA UDIInstrument EUDAMED
- Description
- COMPLETE GM TRY-IN KIT FDA UDI
Identifiers
- Catalog Number
- 110.305 FDA UDI
- Primary DI / UDI-DI
- 07899878033608 EUDAMEDFDA UDI
- Basic UDI-DI
- 987800085VZ EUDAMED
- 510(k) Number
- K182865 FDA UDI
- FDA Product Code
- KCT FDA UDI
- EMDN Code
- L99 SURGICAL INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6850 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
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
Yes
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 — 195 Millimeter FDA UDI
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
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 Dental/maxillofacial surgical procedure kit, non-medicated, reusable.
- Dental Elevator Combo Set — SONTEC INSTRUMENTS, INC. · Class I
- Positioning Guide Full KIT — OSSTEM IMPLANT CO.,LTD · Class IIa
- Implantium, Superline — Dentium Co., Ltd. · Class I
- Bone Management — Hager & Meisinger Gesellschaft mit beschränkter Haftung · Class I
- Ditron Dental — DITRON DENTAL LTD · Class I
- KLOCKNER — SOADCO, S.L. · Class II
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- Osteo KIT — OSSTEM IMPLANT Co., Ltd. · Class I
Cleared under the same submission
K182865 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.
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 18cccc54-87ed-4e67-8e45-77b667b9ff62 38 fields · synced Oct 6, 2026
- EUDAMED 38c19d89-5aac-41b6-a5b9-360cfdb407b5 61 fields · synced Jul 20, 2026