REF-LINE - Resin Artificial Teeth - POLIDENT d.o.o.

Duns Number:644778409

Device Description: Resin Artificial Teeth

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More Product Details

Catalog Number

REF.V6A9

Brand Name

REF-LINE

Version/Model Number

REF.V6A9

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Safe

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)

-

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

ELM

Product Code Name

Denture, plastic, teeth

Device Record Status

Public Device Record Key

67a3b733-c364-4a8e-8126-442f800be7a4

Public Version Date

June 23, 2021

Public Version Number

1

DI Record Publish Date

June 15, 2021

Additional Identifiers

Package DI Number

EPOLREFV6A903

Quantity per Package

1

Contains DI Package

EPOLREFV6A9

Package Discontinue Date

June 15, 2021

Package Status

Not in Commercial Distribution

Package Type

plastic card

"POLIDENT D.O.O." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 3891