New Shade Plus Ant 1217463

GUDID 10304040000967

New Shade Plus Ant

HENRY SCHEIN, INC.

Resin artificial teeth
Primary Device ID10304040000967
NIH Device Record Keyf54e10ad-10fb-47b2-bf38-108ebadb79c6
Commercial Distribution StatusIn Commercial Distribution
Brand NameNew Shade Plus Ant
Version Model Number1217463
Catalog Number1217463
Company DUNS012430880
Company NameHENRY SCHEIN, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 23 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100304040000960 [Primary]
GS110304040000967 [Package]
Contains: 00304040000960
Package: BOX [20 Units]
In Commercial Distribution

FDA Product Code

ELMDenture, plastic, teeth

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-24

Devices Manufactured by HENRY SCHEIN, INC.

00304040194775 - Henry Schein2026-02-04 Custom Plastics Pack
00304040194812 - Henry Schein2026-02-04 Abdominoplasty Pack
00304040194829 - Henry Schein2026-02-04 Basic Pack PSSC002-01 (TBD)
00304040194836 - Henry Schein2026-02-04 Breast Pack PSSC003-01 (TBD)
00304040194843 - Henry Schein2026-02-04 Head and Neck Pack PSSC004-01 (TBD)
00304040194782 - Henry Schein2026-01-28 Essentials Mixing Tips Large
00304040194799 - Henry Schein2026-01-28 Essentials Mixing Tips Small
00304040194805 - Henry Schein2026-01-28 Essentials Intraoral Tips

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.