SmileSet Impression Kit - Night Guard

GUDID 00850078989376

Ortho Dental Lab LLC

Dental impression material kit, single-use

• Primary Device ID: 00850078989376
• NIH Device Record Key: c7ded9e9-6bac-4c8f-a833-6c72d67b3dc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SmileSet Impression Kit - Night Guard
• Version Model Number: 110-0102
• Company DUNS: 119338749
• Company Name: Ortho Dental Lab LLC
• 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: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• 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: true

Customer Support Contacts

• Phone: 1-855-604-7052
• Email: support@smileset.com
• Phone: 1-855-604-7052
• Email: support@smileset.com
• Phone: 1-855-604-7052
• Email: support@smileset.com
• Phone: 1-855-604-7052
• Email: support@smileset.com
• Phone: 1-855-604-7052
• Email: support@smileset.com
• Phone: 1-855-604-7052
• Email: support@smileset.com
• Phone: 1-855-604-7052
• Email: support@smileset.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850078989376 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000629

FDA Product Code

• ELW: Material, Impression

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: 2026-03-30
• Device Publish Date: 2026-03-20

Devices Manufactured by Ortho Dental Lab LLC

• 00850078989369 - SmileSet Impression Kit - Retainer: 2026-03-30
• 00850078989376 - SmileSet Impression Kit - Night Guard: 2026-03-30
• 00850078989376 - SmileSet Impression Kit - Night Guard: 2026-03-30
• 00850078989109 - SmileSet Sonic Toothbrush Refill Heads - Black with Mint: 2025-10-03
• 00850078989116 - SmileSet Sonic Toothbrush Refill Heads - White with Mint: 2025-10-03
• 00850078989123 - SmileSet Premium Whitening Kit – Black: 2025-10-03
• 00850078989130 - SmileSet Premium Whitening Kit – Mint: 2025-10-03
• 00850078989147 - SmileSet Premium Whitening Kit – White: 2025-10-03
• 00850078989154 - SmileSet Premium Whitening Refill – 4 Pack: 2025-10-03