20:1 CONTRA ANGLE - BONART CO., LTD.

Duns Number:657263687

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More Product Details

Catalog Number

-

Brand Name

20:1 CONTRA ANGLE

Version/Model Number

LCC-120A

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K162856

Product Code Details

Product Code

EGS

Product Code Name

Handpiece, Contra- And Right-Angle Attachment, Dental

Device Record Status

Public Device Record Key

14e58fa3-a6a4-4e15-910c-49ad6a4f4441

Public Version Date

December 13, 2018

Public Version Number

1

DI Record Publish Date

November 12, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BONART CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5
2 A medical device with a moderate to high risk that requires special controls. 131