SPHERO BLOCK NORMO - Titanium abutment designed as an endosseous - RHEIN 83 SRL

Duns Number:439240722

Device Description: Titanium abutment designed as an endosseous dental implant retentive component used to ret Titanium abutment designed as an endosseous dental implant retentive component used to retain a complete or partial denture. The device is screwed into an endosseous implant in the mandible or maxilla.

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More Product Details

Catalog Number

002BRK4R

Brand Name

SPHERO BLOCK NORMO

Version/Model Number

SPHERO BLOCK NORMO BRANEMARK h.4 TiN

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

-

Product Code Details

Product Code

DZE

Product Code Name

Implant, Endosseous, Root-Form

Device Record Status

Public Device Record Key

0bbe8aa2-8a3f-42c9-b67b-db8c287aaacc

Public Version Date

June 17, 2022

Public Version Number

1

DI Record Publish Date

June 09, 2022

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