Spark

GUDID 00889989087635

Attachment Template

ORMCO CORPORATION

Orthodontic progressive aligner

• Primary Device ID: 00889989087635
• NIH Device Record Key: 4a8ba0a8-e80c-46d5-98a9-27fe6d76cf67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spark
• Version Model Number: 728-3009
• Company DUNS: 154614119
• Company Name: ORMCO CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com
• Phone: +18008541741
• Email: ormcocustcare@ormco.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889989087635 [Primary]

FDA Product Code

• NXC: Aligner, sequential

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: 2023-08-31
• Device Publish Date: 2023-08-23

On-Brand Devices [Spark]

• 00889989084870: Spark Advanced - Reorder
• 00889989084863: Spark Advanced - Refinement
• 00889989084856: Spark Advanced - Single Arch
• 00889989084849: Spark 20 / Active - Reorder
• 00889989084832: Spark 20 / Active - Refinement
• 00889989084825: Spark 20 / Active - Single Arch
• 00889989084818: Spark 10 / Apt - Reorder
• 00889989084801: Spark 10 / Apt - Refinement
• 00889989084795: Spark 10 / Apt - Single Arch
• 00889989083460: Spark Advanced - Dual Arch
• 00889989083453: Spark 20 / Active - Dual Arch
• 00889989083446: Spark 10 / Apt - Dual Arch
• 00889989087635: Attachment Template
• 00889989087628: ALIGNERS - MFD - CARRIER (MP100)
• 00889989087611: ALIGNERS - MFD - CARRIER (ZENDURA ROLL)
• 00889989087604: XL ALIGNER KIT 1 ALT