Enamel Plus Temp ® - ENAMEL PLUS TEMP INTRODUCTORY KIT- 1 TEMP1-CLEAR; - MICERIUM SPA

Duns Number:436661136

Device Description: ENAMEL PLUS TEMP INTRODUCTORY KIT- 1 TEMP1-CLEAR; TEMP CLEAR 10g- 1 TEMP1-DOD; TEMP DOD 10 ENAMEL PLUS TEMP INTRODUCTORY KIT- 1 TEMP1-CLEAR; TEMP CLEAR 10g- 1 TEMP1-DOD; TEMP DOD 10g- 1 TEMP1-DOL; TEMP DOL 10g- 1 TEMP1-GREY; TEMP GREY 10g- 1 TEMP1-MO; TEMP MO (orange) 10g- 1 TEMP1-MY; TEMP MY (yellow) 10g- 1 TEMP1-PINK; TEMP PINK 10g- 1 TEMP1-UD0; TEMP UD0 10g- 1 TEMP1-UD1; TEMP UD1 10g- 1 TEMP1-UD5; TEMP UD5 10g- 1 TEMP1-UE1; TEMP UE1 10g- 1 TEMP1-UE3; TEMP UE3 10g- 1 TEMP1-WHITE; TEMP WHITE 10g- 1 TEMPL Self Curing 100 ml Liquid- 1 TEMPLC ENAMEL plus TEMP LIQ. FOTOP. 10ml - 1 TEMP50BLUE, BLUE 50G POWDER- 1 TEMP50UD2, UD2 50g POWDER- 1 TEMP50UD3, UD3 50g POWDER- 1 TEMP50UD3,5 UD3.5 50g POWDER- 1 TEMP50UD4, UD4 50g POWDER- 1 TEMP50UE2, UE2 50g POWDER

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More Product Details

Catalog Number

TEMP1N-OF

Brand Name

Enamel Plus Temp ®

Version/Model Number

TEMP1N-OF

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K103474

Product Code Details

Product Code

EBG

Product Code Name

Crown And Bridge, Temporary, Resin

Device Record Status

Public Device Record Key

5eb38096-fe85-4e93-b58f-b26f7a0d1ac5

Public Version Date

December 10, 2021

Public Version Number

1

DI Record Publish Date

December 02, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MICERIUM SPA" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 32
2 A medical device with a moderate to high risk that requires special controls. 231