BioHorizons - Tapered Pro 3DS, Ø4.2 x 12mm(L), RBT w/Laser-Lok - BIOHORIZONS IMPLANT SYSTEMS, INC

Duns Number:967279910

Device Description: Tapered Pro 3DS, Ø4.2 x 12mm(L), RBT w/Laser-Lok

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More Product Details

Catalog Number

-

Brand Name

BioHorizons

Version/Model Number

3DS4212

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

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

K071638,K143022

Product Code Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

3464beb3-63a8-44cf-b957-1ac39cd28aca

Public Version Date

September 27, 2021

Public Version Number

1

DI Record Publish Date

September 17, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOHORIZONS IMPLANT SYSTEMS, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 569
2 A medical device with a moderate to high risk that requires special controls. 982