CEKA & PRECI-LINE ATTACHMENTS - Precision Reamer - Alphadent NV

Duns Number:283174985

Device Description: Precision Reamer

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More Product Details

Catalog Number

1229

Brand Name

CEKA & PRECI-LINE ATTACHMENTS

Version/Model Number

1229

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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

-

Product Code Details

Product Code

DZA

Product Code Name

DRILL, DENTAL, INTRAORAL

Device Record Status

Public Device Record Key

3aaf697c-ad0f-4a84-b557-cf42e49325bf

Public Version Date

April 21, 2021

Public Version Number

2

DI Record Publish Date

March 30, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ALPHADENT NV" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 346
2 A medical device with a moderate to high risk that requires special controls. 7