Park Dental Research Corp. - 2.0 mm x 17 mm LEW Mini Implant Non-collared - PARK DENTAL RESEARCH CORP

Duns Number:011441508

Device Description: 2.0 mm x 17 mm LEW Mini Implant Non-collared

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More Product Details

Catalog Number

-

Brand Name

Park Dental Research Corp.

Version/Model Number

2017-XO

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K121707

Product Code Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

92b75f9e-913e-4c51-84f3-4c32f8639a1a

Public Version Date

November 14, 2018

Public Version Number

4

DI Record Publish Date

September 16, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PARK DENTAL RESEARCH CORP" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 46
2 A medical device with a moderate to high risk that requires special controls. 62