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I-FIX Angled Type ScanBody

FDA UDI

Class I (US FDA UDI)

by Dentis Co. , Ltd

Identity

Trade Name
I-FIX Angled Type ScanBody FDA UDI
Generic Name
Dental implant abutment analog, intraoral-scanning, single-use FDA UDI
Device Name
I-FIX Angled Type ScanBody (DFASBL) FDA UDI
Model / Reference
DFASBL FDA UDI
Description
I-FIX Angled Type ScanBody (DFASBL) FDA UDI

Identifiers

Primary DI / UDI-DI
08800053064736 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

Yes

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Dental implant abutment analog, intraoral-scanning, single-use

I-FIX Angled Type ScanBody by Dentis Co. , Ltd — 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Dentis Co. , Ltd

Sources (1)

  • FDA UDI c30f6621-0fb3-4b07-9cc6-ebee56900c1d 33 fields · synced Jun 1, 2026