Acero Crowns ES - Light

GUDID 00810120870908

Park - Istre, LLC

Preformed dental crown, temporary
Primary Device ID00810120870908
NIH Device Record Keyc201ee8a-aa60-4477-b08a-c44c49a92444
Commercial Distribution StatusIn Commercial Distribution
Brand NameAcero Crowns ES - Light
Version Model NumberESL F1
Company DUNS006672536
Company NamePark - Istre, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100810120870908 [Primary]

FDA Product Code

ELZCrown, Preformed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-07
Device Publish Date2022-10-30

On-Brand Devices [Acero Crowns ES - Light]

00810120871073ESL U6
00810120871066ESL U5
00810120871059ESL U4
00810120871042ESL U3
00810120871035ESL U2
00810120871028ESL U1
00810120871011ESL G6
00810120871004ESL G5
00810120870991ESL G4
00810120870984ESL G3
00810120870977ESL G2
00810120870960ESL G1
00810120870953ESL F6
00810120870946ESL F5
00810120870939ESL F4
00810120870922ESL F3
00810120870915ESL F2
00810120870908ESL F1
00810120870892ESL E6
00810120870885ESL E5
00810120870878ESL E4
00810120870861ESL E3
00810120870854ESL E2
00810120870847ESL E1
00810120870830ESL D6
00810120870823ESL D5
00810120870816ESL D4
00810120870809ESL D3
00810120870793ESL D2
00810120870786ESL D1

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