Acero Z1 Molar

GUDID 00810120872230

Park - Istre, LLC

Preformed dental crown, temporary

• Primary Device ID: 00810120872230
• NIH Device Record Key: 2e1b81bb-d40e-484c-b05c-4a8f79e47bc9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acero Z1 Molar
• Version Model Number: Z1 A6
• 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	00810120872230 [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 Z1 Molar]

• 00810120872797: Z1 T6
• 00810120872780: Z1 T5N
• 00810120872773: Z1 T5
• 00810120872766: Z1 T4N
• 00810120872759: Z1 T4
• 00810120872742: Z1 T3N
• 00810120872735: Z1 T3
• 00810120872728: Z1 T2
• 00810120872711: Z1 S6
• 00810120872704: Z1 S5N
• 00810120872698: Z1 S5
• 00810120872681: Z1 S4N
• 00810120872674: Z1 S4
• 00810120872667: Z1 S3N
• 00810120872650: Z1 S3
• 00810120872643: Z1 S2
• 00810120872636: Z1 L6
• 00810120872629: Z1 L5N
• 00810120872612: Z1 L5
• 00810120872605: Z1 L4N
• 00810120872599: Z1 L4
• 00810120872582: Z1 L3N
• 00810120872575: Z1 L3
• 00810120872568: Z1 L2
• 00810120872551: Z1 K6
• 00810120872544: Z1 K5N
• 00810120872537: Z1 K5
• 00810120872520: Z1 K4N
• 00810120872513: Z1 K4
• 00810120872506: Z1 K3N
• 00810120872490: Z1 K3
• 00810120872483: Z1 K2
• 00810120872476: Z1 J6
• 00810120872469: Z1 J5N
• 00810120872452: Z1 J5
• 00810120872445: Z1 J4N
• 00810120872438: Z1 J4
• 00810120872421: Z1 J3N
• 00810120872414: Z1 J3
• 00810120872407: Z1 J2
• 00810120872391: Z1 I6
• 00810120872384: Z1 I5N
• 00810120872377: Z1 I5
• 00810120872360: Z1 I4N
• 00810120872353: Z1 I4
• 00810120872346: Z1 I3N
• 00810120872339: Z1 I3
• 00810120872322: Z1 I2
• 00810120872315: Z1 B6
• 00810120872308: Z1 B5N