Scan Abutment - AnyOne Interal System Ø4.3/ C=1/ S/ C-type - Megagen Implant Co. Ltd

Duns Number:687388178

Device Description: AnyOne Interal System Ø4.3/ C=1/ S/ C-type

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More Product Details

Catalog Number

AOICSS3810T

Brand Name

Scan Abutment

Version/Model Number

AOICSS3810

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

9e51cc1d-354e-45bb-98cc-02927f06c4b1

Public Version Date

February 28, 2019

Public Version Number

1

DI Record Publish Date

January 28, 2019

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