DiamondCrown-DCBLOK - DiamondCrown-DCBLOK(CADCAM)-I-10mm A1/B1 - - DRM RESEARCH LABORATORIES INC

Duns Number:809646136

Device Description: DiamondCrown-DCBLOK(CADCAM)-I-10mm A1/B1 - DRM-Laminate/Veneer/Inlay/Onlay/Crown-CADCAM-BL DiamondCrown-DCBLOK(CADCAM)-I-10mm A1/B1 - DRM-Laminate/Veneer/Inlay/Onlay/Crown-CADCAM-BLOK-PolyCeramRestorative Materials, Dental Crown & Bridge, Accessories, Implant Dental - Endosseous, ZTi-DiamondCrown-Integrated-Implant-Superstructure System, Permanent, Preformed

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More Product Details

Catalog Number

DCBK701

Brand Name

DiamondCrown-DCBLOK

Version/Model Number

DCBLOK-I-10mm A1/B1

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

1f299ed1-4791-44dc-b451-7b8d87915513

Public Version Date

June 30, 2020

Public Version Number

1

DI Record Publish Date

June 22, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"DRM RESEARCH LABORATORIES INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10