Cavex Baseplate lowers - Dental Wax - Cavex Holland B.V.

Duns Number:419980156

Device Description: Dental Wax

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More Product Details

Catalog Number

BP054

Brand Name

Cavex Baseplate lowers

Version/Model Number

BP054

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

EEA

Product Code Name

Plate, Base, Shellac

Device Record Status

Public Device Record Key

286d7f32-982b-49b4-b1bf-511061b3bae5

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

July 07, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CAVEX HOLLAND B.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 33
2 A medical device with a moderate to high risk that requires special controls. 52