DENTAL ATTACHMENTS - Sterilizable device for the dental impression - RHEIN 83 SRL

Duns Number:439240722

Device Description: Sterilizable device for the dental impression

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More Product Details

Catalog Number

044CAIN-IQ

Brand Name

DENTAL ATTACHMENTS

Version/Model Number

Impression coping (4 Pack)

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

Yes

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

NDP

Product Code Name

Accessories, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

fdf1071f-4f7f-4155-92be-ff35cd860a5d

Public Version Date

July 28, 2021

Public Version Number

1

DI Record Publish Date

July 20, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RHEIN 83 SRL" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1269
2 A medical device with a moderate to high risk that requires special controls. 1987