Heat Source For Bleaching Teeth
The Heat Source for Bleaching Teeth is a dental device used to generate and apply heat to activate bleaching agents during in-office tooth whitening procedures, accelerating the chemical reaction that lightens tooth stains and discoloration. It is classified as FDA Class 1, the lowest risk category, subject only to general controls and no premarket submission is required. The product code is EEG and the applicable regulation is 21 CFR 872.6475, under the Dental medical specialty.
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Basic Information
- Product Code
- EEG
- Device Class
- FDA class 1
- Regulation Number
- 872.6475
- Medical Specialty
- Dental
- Review Panel
- DE
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 12 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K122725 | TANDA PEARL, ULTRAWYTE, PEARL | Nov 27, 2012 | Substantially Equivalent | Syneron Beauty |
| K110888 | ABSOLUTE WHITE LIGHT | Jan 12, 2012 | Substantially Equivalent | Dr. Fresh, Inc. |
| K063704 | BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 | Feb 20, 2007 | Substantially Equivalent | Beks Incorporated |
| K052040 | QUICKSMILE | Oct 18, 2005 | Substantially Equivalent | Cosmetic Dental Materials, Inc. |
| K042153 | SOUTH BEACH SMILE LIGHT WHITENING SYSTEM | Nov 08, 2004 | Substantially Equivalent | Dentovations, Inc. |
| K041392 | SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US | Nov 08, 2004 | Substantially Equivalent | CAO Group, Inc. |
| K895174 | UNION BROACH BLEACHING LIGHT | Apr 13, 1990 | Substantially Equivalent | Union Broach, Div. Moyco Industries, Inc. |
| K884937 | BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING | Apr 14, 1989 | Substantially Equivalent | Grass-Telefactor Product Group |
| K862385 | SCHEIN BLEACHING UNIT | Oct 30, 1986 | Substantially Equivalent | Henry Schein, Inc. |
| K854692 | MONARCH II BLEACHING INSTRUMENT | May 12, 1986 | Substantially Equivalent | Almore Intl., Inc. |
| K832179 | HOT PROBE MODEL 6001 | Oct 04, 1983 | Substantially Equivalent | Analytic Technology |
| K790378 | REYNOLDS BLEACHING PROCESS | Apr 10, 1979 | Substantially Equivalent | Reynolds Laboratories |
FEI Numbers
This FDA classification entry is associated with 115 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 116 registration numbers. Click on an entry to view related FDA registrations.