Meg-Loc Abutment - AnyOne OneStage C=4/ Slot - Megagen Implant Co. Ltd

Duns Number:687388178

Device Description: AnyOne OneStage C=4/ Slot

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

MLSOO04

Brand Name

Meg-Loc Abutment

Version/Model Number

MLSOO04

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

K192614

Product Code Details

Product Code

NHA

Product Code Name

Abutment, Implant, Dental, Endosseous

Device Record Status

Public Device Record Key

e68daca9-4e00-44be-a644-dcc13ed53f12

Public Version Date

July 09, 2021

Public Version Number

1

DI Record Publish Date

July 01, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEGAGEN IMPLANT CO. LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1261
2 A medical device with a moderate to high risk that requires special controls. 3498