Identity
- Trade Name
- VARIOmulti temporary cap FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Model / Reference
- 3.03.803 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07640156478099 FDA UDI
- 510(k) Number
- K072856 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
Yes
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Dental implant suprastructure, temporary, preformed, single-use
The VARIOmulti temporary cap is a dental implant suprastructure, temporary, preformed, single-use device designed for use during dental implant restorative and laboratory procedures. It provides a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, helping to promote oral soft-tissue healing and sculpting.
Similar devices
Also classified as Dental implant suprastructure, temporary, preformed, single-use.
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Intraoral Scanbody — ARUM DENTISTRY Co., Ltd. · Class I
- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
- Impression Coping — ARUM DENTISTRY Co., Ltd. · Class I
- Neoss Implant System — Neoss, Ltd. · Class II
- Scanbody Screw — ARUM DENTISTRY Co., Ltd. · Class I
Cleared under the same submission
K072856 also covers:
- SPI EASY — Thommen Medical AG
- SPI EASY — Thommen Medical AG
- SPI RETAIN — Thommen Medical AG
- SPI TEMPORARY — Thommen Medical AG
- SPI VARIO — Thommen Medical AG
- SPI VARIO — Thommen Medical AG
- SPI VARIO — Thommen Medical AG
- SPI VARIO — Thommen Medical AG
- SPI VARIO — Thommen Medical AG
- SPI VARIO — Thommen Medical AG
- SPI VARIO — Thommen Medical AG
- SPI VARIO — Thommen Medical AG
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Thommen Medical AG
Sources (1)
- FDA UDI 5b621b8e-221f-4022-ad16-93933136b132 33 fields · synced Oct 7, 2026