Catalog Number

TOM48A30S

Brand Name

neo.lign A tooth

Version/Model Number

TOM48A30S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ELM

Product Code Name

Denture, plastic, teeth

Public Device Record Key

e84a95d8-170a-4135-95d4-ac5fab990160

Public Version Date

March 10, 2021

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

EBRETOM48A30S9

Quantity per Package

1

Contains DI Package

EBRETOM48A30S0

Package Discontinue Date

September 21, 2016

Package Status

Not in Commercial Distribution

Package Type

dummy