TRU/PUR 4.5mm Drill 6,8,10,12,14mm - A metal device used in dental surgery to create - STERNGOLD DENTAL LLC

Duns Number:124763728

Device Description: A metal device used in dental surgery to create channels of appropriate depth and diameter A metal device used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. There are depth marks along the length of some drills corresponding to the different size implant bodies. These marks are laser etched. Some drills are marked with the diameter in millimeters on the shank. Intended to be used to generate the bore into the bone into which an implant body or attachment is installed into.

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More Product Details

Catalog Number

-

Brand Name

TRU/PUR 4.5mm Drill 6,8,10,12,14mm

Version/Model Number

905291

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

-

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

K150968

Product Code Details

Product Code

DZI

Product Code Name

Drill, Bone, Powered

Device Record Status

Public Device Record Key

a05b5e3a-4562-464e-bd9a-3b337bbf90ef

Public Version Date

January 09, 2020

Public Version Number

5

DI Record Publish Date

July 05, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"STERNGOLD DENTAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 1346