Product code EEG
- Device name
- Heat Source For Bleaching Teeth
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.6475
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K122725 | TANDA PEARL, ULTRAWYTE, PEARL | Syneron Beauty | 2012-11-27 |
| K110888 | ABSOLUTE WHITE LIGHT | Dr. Fresh, Inc. | 2012-01-12 |
| K063704 | BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 | Beks Incorporated | 2007-02-20 |
| K052040 | QUICKSMILE | Cosmetic Dental Materials, Inc. | 2005-10-18 |
| K041392 | SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US | CAO Group, Inc. | 2004-11-08 |
| K042153 | SOUTH BEACH SMILE LIGHT WHITENING SYSTEM | Dentovations, Inc. | 2004-11-08 |
| K895174 | UNION BROACH BLEACHING LIGHT | Union Broach, Div. Moyco Industries, Inc. | 1990-04-13 |
| K884937 | BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING | Grass-Telefactor Product Group | 1989-04-14 |
| K862385 | SCHEIN BLEACHING UNIT | Henry Schein, Inc. | 1986-10-30 |
| K854692 | MONARCH II BLEACHING INSTRUMENT | Almore Intl., Inc. | 1986-05-12 |
| K832179 | HOT PROBE MODEL 6001 | Analytic Technology | 1983-10-04 |
| K790378 | REYNOLDS BLEACHING PROCESS | Reynolds Laboratories | 1979-04-10 |
Related GUDID Devices#
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|---|---|---|---|
| 00872320006440 | Picasso Pro Diode Laser | CAO GROUP, INC. | 2026-04-10 |
| E241WR0100 | WR Premium Perfection Kit Led EU | Cavex Holland B.V. | 2026-03-09 |
| 08719327516041 | WR Premium Perfection Kit + Led | Cavex Holland B.V. | 2026-03-09 |
| E241WR0040 | WR Premium Perfection Kit + Led | Cavex Holland B.V. | 2026-03-09 |
| E241BW0070 | Cavex Bite&White 3 syringes CP16 | Cavex Holland B.V. | 2026-03-05 |
| E241BW1600 | Cavex Bite&White ExSense tube | Cavex Holland B.V. | 2026-03-05 |
| E241BW0620 | Cavex Bite&White ExSense Brushpen | Cavex Holland B.V. | 2026-03-05 |
| 00301260033211 | Colgate Optic White Professional In Office Whitening Kit | COLGATE ORAL PHARMACEUTICALS, INC. | 2025-11-06 |
| 00860012825530 | SmileDirectClub Whitening Pen - 4 Pack Plus Light | Ortho Dental Lab LLC | 2025-10-16 |
| 00860012825516 | SmileDirectClub Whitening Pen - 9 Pack Plus Light | Ortho Dental Lab LLC | 2025-10-16 |
| 00850078989147 | SmileSet Premium Whitening Kit – White | Ortho Dental Lab LLC | 2025-09-25 |
| 00850078989130 | SmileSet Premium Whitening Kit – Mint | Ortho Dental Lab LLC | 2025-09-25 |
| 00850078989123 | SmileSet Premium Whitening Kit – Black | Ortho Dental Lab LLC | 2025-09-25 |
| E22190021 | Caps Warmer | VOCO GmbH | 2024-05-07 |
| D7077563421 | Vivastyle | IVOCLAR VIVADENT, INC. | 2023-11-02 |
| 07290113770010 | Mavrik Dental System | Mavrik Dental System Inc. | 2023-11-01 |
| 07290113770034 | Mavrik Dental System | Mavrik Dental System Inc. | 2023-11-01 |
| 04719883751379 | APOZA | APOZA ENTERPRISE CO., LTD. | 2023-06-28 |
| 00035000990754 | Colgate Optic White Professional Take-Home Whitening Kit | COLGATE ORAL PHARMACEUTICALS, INC. | 2023-06-08 |
| 04061464611665 | Dentiguard | Aldi Inc. | 2023-02-13 |
| 00857848007728 | BEYOND® II Ultra Whitening Accelerator | Beyond International Inc. | 2022-12-23 |
| 00857848007711 | BEYOND® Polus® Advanced Ultra Whitening Accelerator | Beyond International Inc. | 2022-12-23 |
| 00857848007131 | BEYOND® II Whitening Accelerator | Beyond International Inc. | 2022-12-23 |
| 00857848007124 | BEYOND® Polus® Advanced Whitening Accelerator | Beyond International Inc. | 2022-12-23 |
| 00628634327043 | PhytoLight | PhotoDynamic Incorporated | 2022-12-19 |
| E22190031 | Caps Warmer | VOCO GmbH | 2021-02-02 |
| 08710103632122 | Philips Zoom | Discus Dental, LLC | 2020-09-23 |
| E22160631 | VisCalor bulk | VOCO GmbH | 2019-05-10 |
| E22190011 | Caps Warmer | VOCO GmbH | 2017-12-21 |
| D724A1902001 | Vivid KoolWhite | PEARSON DENTAL SUPPLIES, INC. | 2016-08-23 |