Identity
- Trade Name
- Medentika FDA UDI
- Generic Name
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
- Device Name
- Scanbody FDA UDI
- Model / Reference
- E 1400-SB FDA UDI
- Description
- Scanbody FDA UDI
Identifiers
- Catalog Number
- E 1400-SB FDA UDI
- Primary DI / UDI-DI
- 04251574865755 FDA UDI
- FDA Product Code
- NDP FDA UDI
- GMDN Term
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3980 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
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 implant abutment analog, intraoral-scanning, single-use
Medentika by Medentika GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental implant abutment analog, intraoral-scanning, single-use.
- SET ZZ BASE NB-Z-WSM B4.1 — Zirkonzahn GmbH · Class I
- DIO Zimmer Scan Adapter — DIO Corporation · Class I
- Zirlux — HENRY SCHEIN, INC. · Class I
- Preat Implant Prosthetics — PREAT Corporation · Class I
- TruScan body — Truabutment Korea Co., Ltd · Class I
- DIRECTscan™ Adapter Single Wing-A — APOLLO IMPLANT COMPONENTS SP Z O O · Class I
- Azure — TERRATS MEDICAL SL. · Class I
- SET ZZ BASE C-J-WSM 4.3 — Zirkonzahn GmbH · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medentika GmbH
Sources (1)
- FDA UDI 1e62a760-e495-4a8a-9ad2-129dfcb91034 34 fields · synced May 31, 2026