Smilers - GOUTP for 2 archs - BIOTECH DENTAL SMILERS

Duns Number:266048588

Device Description: GOUTP for 2 archs

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More Product Details

Catalog Number

GOUTP

Brand Name

Smilers

Version/Model Number

Attachement placement aligner

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Safe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K212961,K212961

Product Code Details

Product Code

NXC

Product Code Name

Aligner, Sequential

Device Record Status

Public Device Record Key

e5fbe24f-da2c-4e91-bbf6-9cb552dbea0f

Public Version Date

April 28, 2022

Public Version Number

1

DI Record Publish Date

April 20, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOTECH DENTAL SMILERS" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9