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Smile stretcher-purple bag

FDA UDI

Class I (US FDA UDI)

by Access Dental Lab, LLC

Identity

Trade Name
Smile stretcher-purple bag FDA UDI
Generic Name
Dental cheek retractor, home-use FDA UDI
Device Name
Smile stretcher in foil purple pouch FDA UDI
Model / Reference
200-0049 FDA UDI
Description
Smile stretcher in foil purple pouch FDA UDI

Identifiers

Primary DI / UDI-DI
00850007728342 FDA UDI
FDA Product Code
EIG FDA UDI
GMDN Term
Dental cheek retractor, home-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

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

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: Dental cheek retractor, home-use

Smile stretcher-purple bag by Access Dental Lab, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental cheek retractor, home-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 0ab85301-0e37-4a1c-92db-65af35f4a730 33 fields · synced Jun 8, 2026