UltraPrint-Dental Denture Teeth UV - 1000g, UltraPrint-Dental Denture Teeth UV-B1 - GUANGZHOU HEYGEARS IMC.INC

Duns Number:418561545

Device Description: 1000g, UltraPrint-Dental Denture Teeth UV-B1

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More Product Details

Catalog Number

-

Brand Name

UltraPrint-Dental Denture Teeth UV

Version/Model Number

1.0

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PZY

Product Code Name

Additively Manufactured, Preformed, Resin Denture Tooth

Device Record Status

Public Device Record Key

6d6a0669-47ce-473b-b38f-2f9306c7b668

Public Version Date

October 01, 2021

Public Version Number

1

DI Record Publish Date

September 23, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"GUANGZHOU HEYGEARS IMC.INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 64