Primary Device ID | 00850078989093 |
NIH Device Record Key | aa7e431a-f7ba-4640-a443-68800bf00790 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SmileSet Sonic Toothbrush – White with Mint Accents |
Version Model Number | 150-0106 |
Company DUNS | 119338749 |
Company Name | Ortho Dental Lab 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 | false |
Lot Batch | false |
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 | true |
Phone | 1-855-604-7052 |
support@smileset.com | |
Phone | 1-855-604-7052 |
support@smileset.com | |
Phone | 1-855-604-7052 |
support@smileset.com | |
Phone | 1-855-604-7052 |
support@smileset.com | |
Phone | 1-855-604-7052 |
support@smileset.com | |
Phone | 1-855-604-7052 |
support@smileset.com | |
Phone | 1-855-604-7052 |
support@smileset.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00850078989093 [Primary] |
JEQ | Toothbrush, Powered |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-09-12 |
Device Publish Date | 2025-09-04 |
00850078989086 - SmileSet Sonic Toothbrush – Black with Mint Accents | 2025-09-12 |
00850078989093 - SmileSet Sonic Toothbrush – White with Mint Accents | 2025-09-12 |
00850078989093 - SmileSet Sonic Toothbrush – White with Mint Accents | 2025-09-12 |
00860014476136 - SmileSet Night Guard | 2025-09-12 |
00860012825592 - SmileSet Retainers | 2025-09-11 |
00860014476105 - SmileSet Nighttime Aligners | 2025-09-11 |
00860012825509 - SmileSet All-Day Aligners | 2025-09-05 |