Acero Crowns ES

GUDID 00810120870748

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: 00810120870748
• NIH Device Record Key: 98b2ae1f-58aa-4eb7-a3b9-a84009fdf38f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acero Crowns ES
• Version Model Number: ES U3
• 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	00810120870748 [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]

• 00810120870779: ES U6
• 00810120870762: ES U5
• 00810120870755: ES U4
• 00810120870748: ES U3
• 00810120870731: ES U2
• 00810120870724: ES U1
• 00810120870717: ES G6
• 00810120870700: ES G5
• 00810120870694: ES G4
• 00810120870687: ES G3
• 00810120870670: ES G2
• 00810120870663: ES G1
• 00810120870656: ES F6
• 00810120870649: ES F5
• 00810120870632: ES F4
• 00810120870625: ES F3
• 00810120870618: ES F2
• 00810120870601: ES F1
• 00810120870595: ES E6
• 00810120870588: ES E5
• 00810120870571: ES E4
• 00810120870564: ES E3
• 00810120870557: ES E2
• 00810120870540: ES E1
• 00810120870533: ES D6
• 00810120870526: ES D5
• 00810120870519: ES D4
• 00810120870502: ES D3
• 00810120870496: ES D2
• 00810120870489: ES D1