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Set iOptima + BRACKET

FDA UDI

Class I (US FDA UDI)

by Bien-Air Dental SA

Identity

Trade Name
Set iOptima + BRACKET FDA UDI
Generic Name
Surgical power tool system control unit, line-powered FDA UDI
Device Name
Sets of iOptima systems and their dental micromotors plus relevant accessories FDA UDI
Model / Reference
1700563-001 FDA UDI
Description
Sets of iOptima systems and their dental micromotors plus relevant accessories FDA UDI

Identifiers

Catalog Number
1700563-001 FDA UDI
Primary DI / UDI-DI
J00717005630011 FDA UDI
FDA Product Code
EIA FDA UDI
GMDN Term
Surgical power tool system control unit, line-powered FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.6640 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Surgical power tool system control unit, line-powered

Set iOptima + BRACKET by Bien-Air Dental SA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical power tool system control unit, line-powered.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Bien-Air Dental SA

Sources (1)

  • FDA UDI 92c5b2f5-9930-4256-938c-292ee853028c 35 fields · synced May 30, 2026