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Kör

FDA UDI

Class I (US FDA UDI)

by Evolve Dental Technologies, Inc.

Identity

Trade Name
KöR FDA UDI
Generic Name
Dental cheek retractor, professional, single-use FDA UDI
Device Name
Dental cheek retractor and suction tip. FDA UDI
Model / Reference
KöR Retractor & Suction Tip (Max) FDA UDI
Description
Dental cheek retractor and suction tip. FDA UDI

Identifiers

Catalog Number
80-1006 FDA UDI
Primary DI / UDI-DI
00850362007113 FDA UDI
FDA Product Code
BRW FDA UDI
DYN FDA UDI
GMDN Term
Dental cheek retractor, professional, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
868.5820 FDA UDI
872.6640 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

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Dental cheek retractor, professional, single-useIntraoral dental suction tip holder

Kör by Evolve Dental Technologies, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraoral dental suction tip holder.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Evolve Dental Technologies, Inc.

Sources (1)

  • FDA UDI 4cdee65b-0cd7-47f6-801f-203ff3aa50af 34 fields · synced May 30, 2026