Retainer Kit

FDA UDI

Class I (US FDA UDI)

by Access Dental Lab, LLC

Identity

Trade Name: RETAINER KIT FDA UDI
Generic Name: Orthodontic retainer FDA UDI
Device Name: RETAINER KIT FDA UDI
Model / Reference: 100-0354 FDA UDI
Description: RETAINER KIT FDA UDI

Identifiers

Primary DI / UDI-DI: 00850007728038 FDA UDI
FDA Product Code: KMY FDA UDI
GMDN Term: Orthodontic retainer FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.5525 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Orthodontic retainer

Retainer Kit by Access Dental Lab, LLC — 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: Access Dental Lab, LLC

Sources (1)

FDA UDI 6af0a107-e4e7-46f2-ab7f-6fb97dce23c1 34 fields · synced May 31, 2026