Power Dental U.S.A., Inc. - "C&L SINUS KIT, CRESTAL & LATERAL UNIVERSAL KIT - Power Dental U.S.A. Inc.

Duns Number:081305064

Device Description: "C&L SINUS KIT, CRESTAL & LATERAL UNIVERSAL KIT

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More Product Details

Catalog Number

N7826-0

Brand Name

Power Dental U.S.A., Inc.

Version/Model Number

N7826-0

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

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

MDM

Product Code Name

INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Device Record Status

Public Device Record Key

ab205b05-ca97-4cd3-b105-d6e986371f4e

Public Version Date

July 21, 2021

Public Version Number

1

DI Record Publish Date

July 13, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"POWER DENTAL U.S.A. INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2768
2 A medical device with a moderate to high risk that requires special controls. 18