Anatotemp - Anatotemp Anatomic Dental Implant Healing - BUCKEYE MEDICAL TECHNOLOGIES, LLC

Duns Number:080134511

Device Description: Anatotemp Anatomic Dental Implant Healing Abutment 3.5mmD Platform Internal Tri-Lobe Conne Anatotemp Anatomic Dental Implant Healing Abutment 3.5mmD Platform Internal Tri-Lobe Connection Maxillary Lateral/Mandibular Incisor

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

Anatotemp

Version/Model Number

2035-02

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

K171922

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

97b62cbc-debb-4af9-b8b6-cd78a0d2254f

Public Version Date

December 07, 2018

Public Version Number

4

DI Record Publish Date

December 07, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BUCKEYE MEDICAL TECHNOLOGIES, LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 46