Acero Crowns ES - Light

GUDID 00810120870816

Park - Istre, LLC

Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary Preformed dental crown, temporary

• Primary Device ID: 00810120870816
• NIH Device Record Key: e98c11f3-7a7a-42fa-91f0-237c14da8784
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acero Crowns ES - Light
• Version Model Number: ESL D4
• Company DUNS: 006672536
• Company Name: Park - Istre, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810120870816 [Primary]

FDA Product Code

• ELZ: Crown, Preformed

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-07
• Device Publish Date: 2022-10-30

On-Brand Devices [Acero Crowns ES - Light]

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