510(k) K896481
- Device
- PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER
- Applicant
- PUREBRUSH ASSOC.
- 510(k) number
- K896481
- Product code
- MCF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-05-15
- Date received
- 1989-11-15
- Regulation
- 872.6855
- Classification name
- Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- & SPALDING
- Address
- Edward M. Basile 1730 Pennsylvania Ave., NW Washington DC US 20006 20006
FDA Registration Numbers#
- 3027328721
- 3021368823
- 3011170521
- 3010872518
- 3015514846
- 3030091541
- 3030430667
- 3013685983
- 3012113199
- 3009171220
- 3006115534
- 3023341286
- 3004623350
- 3011139154
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MCF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K023662 | PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER | Hwadong International Company , Ltd. | 2003-05-28 |
| K021258 | GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER | Germ Terminator Corporation | 2002-05-10 |
| K003517 | OTRES TOOTHBRUSH SANITIZER MODEL TB100W | Otres, LLC | 2001-06-06 |
| K901459 | DS60 TOOTHBRUSH SANITIZER | Associated Mills, Inc. | 1990-09-17 |
Legacy Summary#
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FDA Review#
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