Delta Multilayered Translucent A1

GUDID 00816795024677

98X16mm Multilayered Translucent Zirconia Shade A1

AURIDENT INC

Dental porcelain/ceramic restoration kit
Primary Device ID00816795024677
NIH Device Record Keyb9717cba-ee16-4d79-a1e1-6b1e4f3654b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDelta Multilayered Translucent A1
Version Model NumberD816A1MUL/T
Company DUNS030580955
Company NameAURIDENT 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100816795024677 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-04
Device Publish Date2016-10-10

Devices Manufactured by AURIDENT INC

00816795025445 - Delta Zirconia Multilayered Translucent Disc2020-02-13 98X12mm Multilayered Translucent Shade A1
00816795025421 - Delta Zirconia High Translucent Disc2019-11-04 98X10mm High Translucent Shade C3
00816795025643 - Delta Zirconia High Translucent Disc2019-11-04 98X18mm High Translucent Shade D4
08816795025445 - Delta Zirconia Multilayered Translucent Disc2019-11-04 98X12mm Multilayered Translucent Shade A1
00816795024059 - Delta Zirconia2019-11-04 98X10 mm white high strength zirconia disc
00816795024080 - Delta Zirconia Translucent2019-11-04 98x10 mm translucent shade A1
00816795024097 - Delta Zirconia Translucent2019-11-04 98X10mm Translucent Shade A2
00816795024103 - Delta Zirconia Translucent2019-11-04 98X10mm Translucent Shade A3

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