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Aligner Seater Purple

FDA UDI

Class I (US FDA UDI)

by Access Dental Lab, LLC

Identity

Trade Name
ALIGNER SEATER PURPLE FDA UDI
Generic Name
Orthodontic aligner/retainer seater, single-use FDA UDI
Device Name
ALIGNER SEATER WITH PURPLE COLORING FDA UDI
Model / Reference
220-0005 FDA UDI
Description
ALIGNER SEATER WITH PURPLE COLORING FDA UDI

Identifiers

Primary DI / UDI-DI
00850007728410 FDA UDI
FDA Product Code
ECR FDA UDI
GMDN Term
Orthodontic aligner/retainer seater, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 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

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Orthodontic aligner/retainer seater, single-use

Aligner Seater Purple by Access Dental Lab, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthodontic aligner/retainer seater, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Access Dental Lab, LLC

Sources (1)

  • FDA UDI 46fdf04d-a09d-4309-8382-55897d52964d 34 fields · synced May 30, 2026