Filtek™ - 3M™ ESPE™ Filtek™ One Syringe, Bulk Fill, 1 - 4g - 3M COMPANY

Duns Number:830016148

Device Description: 3M™ ESPE™ Filtek™ One Syringe, Bulk Fill, 1 - 4g Syringe, Shade A3, 4866A3

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More Product Details

Catalog Number

4866A3

Brand Name

Filtek™

Version/Model Number

4866A3

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

-

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

EBF

Product Code Name

MATERIAL, TOOTH SHADE, RESIN

Device Record Status

Public Device Record Key

9b345f05-273e-446c-acdf-94a8ed08cba6

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 01, 2017

Additional Identifiers

Package DI Number

50605861062270

Quantity per Package

10

Contains DI Package

30605861062276

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX

"3M COMPANY" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 274
2 A medical device with a moderate to high risk that requires special controls. 444
U Unclassified 7