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Dalbo®-Classic /-B /-Z / Profix

FDA UDI

Class I (US FDA UDI)

by Cendres+Métaux SA

Identity

Trade Name
Dalbo®-Classic /-B /-Z / Profix FDA UDI
Generic Name
Dental precision attachment fitting/adjustment tool FDA UDI
Device Name
Dalbo®-Classic /-B /-Z / Profix Activator FDA UDI
Model / Reference
070197 FDA UDI
Description
Dalbo®-Classic /-B /-Z / Profix Activator FDA UDI

Identifiers

Catalog Number
070197 FDA UDI
Primary DI / UDI-DI
07640166514497 FDA UDI
FDA Product Code
NDP FDA UDI
GMDN Term
Dental precision attachment fitting/adjustment tool 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

Category: Dental precision attachment fitting/adjustment tool

Dalbo®-Classic /-B /-Z / Profix by Cendres+Métaux SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental precision attachment fitting/adjustment tool.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cendres+Métaux SA

Sources (1)

  • FDA UDI 16212674-5271-4c7e-ac1c-2d3d3d11513b 36 fields · synced Jun 8, 2026