Identity
- Trade Name
- Implantium, Superline FDA UDI
- Generic Name
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- Accessories, Implant, Dental, Endosseous FDA UDI
- Model / Reference
- DIC4010N FDA UDI
- Description
- Accessories, Implant, Dental, Endosseous FDA UDI
Identifiers
- Catalog Number
- DIC4010N FDA UDI
- Primary DI / UDI-DI
- 08809740713476 FDA UDI
- 510(k) Number
- K041368 FDA UDI
- FDA Product Code
- DZE FDA UDI
- GMDN Term
- Dental/maxillofacial surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3640 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Conditional FDA UDI
Category: Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Implantium, Superline by Dentium Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — 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
- 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
- UniFit-Standard Internal Star Plastic Surgical Kit-Advanced — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class IIa
Cleared under the same submission
K041368 also covers:
- Implantium — DENTIUM USA
- Implantium — DENTIUM USA
- Implantium — DENTIUM USA
- Implantium — DENTIUM USA
- Implantium — DENTIUM USA
- Implantium — DENTIUM USA
- Implantium — DENTIUM USA
- Implantium — DENTIUM USA
- Implantium — DENTIUM USA
- Implantium, Superline — Dentium Co., Ltd.
- Implantium, Superline — Dentium Co., Ltd.
- Implantium, Superline — Dentium 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Dentium Co., Ltd.
Sources (1)
- FDA UDI 7206b8a2-1172-4dba-861a-7bbea766e8ce 36 fields · synced May 30, 2026