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Ultraflex

FDA UDI

Class II (US FDA UDI)

by Astron Dental

Identity

Trade Name
ULTRAFLEX FDA UDI
Generic Name
Custom-made mouthguard FDA UDI
Device Name
DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER / 240 GRAMS LIQUID FDA UDI
Model / Reference
PUFDFPFEK1 FDA UDI
Description
DENTURE MATERIAL - ECONO KIT - PACKAGE 320 GRAMS POWDER / 240 GRAMS LIQUID FDA UDI

Identifiers

Catalog Number
PUFDFPFEK1 FDA UDI
Primary DI / UDI-DI
D810PUFDFPFEK11 FDA UDI
510(k) Number
K874025 FDA UDI
FDA Product Code
EBI FDA UDI
GMDN Term
Custom-made mouthguard FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3760 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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Custom-made mouthguard

Ultraflex by Astron Dental — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made mouthguard.

Cleared under the same submission

K874025 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Astron Dental

Sources (1)

  • FDA UDI 5ac11598-bcf6-4177-8667-75718a1edc3a 36 fields · synced Jun 8, 2026