OrthoEasy® - Fixation screw for palatinal pin - Forestadent Bernhard Förster GmbH

Duns Number:316074384

Device Description: Fixation screw for palatinal pin

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More Product Details

Catalog Number

-

Brand Name

OrthoEasy®

Version/Model Number

1299-1003

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

Yes

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

NDP

Product Code Name

Accessories, implant, dental, endosseous

Device Record Status

Public Device Record Key

85bc08a6-06f7-4637-8337-7179bd4ce86d

Public Version Date

February 05, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FORESTADENT BERNHARD FÖRSTER GMBH" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5082
2 A medical device with a moderate to high risk that requires special controls. 941