Primary Device ID | 00850078989123 |
NIH Device Record Key | 104125f0-56be-4e6a-a400-9f805eaebeda |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | SmileSet Premium Whitening Kit – Black |
Version Model Number | 150-0119 |
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 | true |
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 | |
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 | 00850078989123 [Primary] |
MAU | Eraser, Dental Stain |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-10-03 |
Device Publish Date | 2025-09-25 |
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 |
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 |
00850078989161 - SmileSet Premium Whitening Sample Pen – 3 ml | 2025-10-03 |
00850078989178 - SmileSet Premium Sensitive Whitening Strips | 2025-10-03 |