OT EQUATOR - OT BRIDGE - DISPOSABLE medical devices. Abutment to be - RHEIN 83 SRL

Duns Number:439240722

Device Description: DISPOSABLE medical devices. Abutment to be screwed into a dental implant. The connection a DISPOSABLE medical devices. Abutment to be screwed into a dental implant. The connection and the thread are compatible with the specific implant; available in different cuff heights. Retentive caps of different retentive forces, metal housing for the caps and protective disc.

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More Product Details

Catalog Number

131MN36

Brand Name

OT EQUATOR - OT BRIDGE

Version/Model Number

OT EQUATOR MINI MN ø 3 h.6 c/SmartBox

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

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

b1052918-bc99-4476-a3bc-d341d02dedfc

Public Version Date

August 09, 2021

Public Version Number

1

DI Record Publish Date

July 30, 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