Identity
- Trade Name
- Dandy Scan Body FDA UDI
- Generic Name
- Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
- Device Name
- Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy. FDA UDI
- Model / Reference
- NCB, Neodent - Cone Morse Ø3.75 FDA UDI
- Description
- Dandy Scan body, by CoreMedTech, for dental Intraoral scanning. This product is made of Titanium for durability with a light-dispersing surface to maximize scanning efficacy. FDA UDI
Identifiers
- Catalog Number
- 80610261 FDA UDI
- Primary DI / UDI-DI
- 05744003810437 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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Dental implant abutment analog, intraoral-scanning, single-use
Dandy Scan Body by Coremedtech ApS — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 |
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Manufacturer
- Manufacturer
- Coremedtech ApS
Sources (1)
- FDA UDI 8c605d27-83ac-4072-9e68-7c5c98ef7e11 36 fields · synced Jun 8, 2026