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Aditek

FDA UDI

Class I (US FDA UDI)

by Aditek Do Brasil S/A

Identity

Trade Name
ADITEK FDA UDI
Generic Name
Dental appliance fabrication material, thermoplastic FDA UDI
Device Name
Sheet Thermoplastic Memoflex PETG 125 X 1.00mm w/3 FDA UDI
Model / Reference
16.38.0005.6 FDA UDI
Description
Sheet Thermoplastic Memoflex PETG 125 X 1.00mm w/3 FDA UDI

Identifiers

Catalog Number
16.38.0005.6 FDA UDI
Primary DI / UDI-DI
07899439216471 FDA UDI
FDA Product Code
DYJ FDA UDI
GMDN Term
Dental appliance fabrication material, thermoplastic FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.5410 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

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental appliance fabrication material, thermoplastic

Aditek by Aditek Do Brasil S/A — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental appliance fabrication material, thermoplastic.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Aditek Do Brasil S/A

Sources (1)

  • FDA UDI 484d9012-4f1b-4a1e-9756-c781d35d8bf5 34 fields · synced May 30, 2026