510(k) K021258
- Device
- GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER
- Applicant
- GERM TERMINATOR CORPORATION
- 510(k) number
- K021258
- Product code
- MCF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-05-10
- Date received
- 2002-04-19
- Regulation
- 872.6855
- Classification name
- Unit, Ultraviolet Sanitation/sterilization (for Toothbrushes), Sterile
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- Yes
Applicant Contact#
- Contact
- DAVID LINK
- Address
- 100 Main St. Suite 120 Concord MA US 01742 01742
FDA Registration Numbers#
- 3027328721
- 3021368823
- 3011170521
- 3010872518
- 3015514846
- 3030091541
- 3030430667
- 3013685983
- 3012113199
- 3009171220
- 3006115534
- 3023341286
- 3004623350
- 3011139154
Source Documents#
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 |
| K003517 | OTRES TOOTHBRUSH SANITIZER MODEL TB100W | Otres, LLC | 2001-06-06 |
| K901459 | DS60 TOOTHBRUSH SANITIZER | Associated Mills, Inc. | 1990-09-17 |
| K896481 | PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER | Purebrush Assoc. | 1990-05-15 |
Legacy Summary#
summary
FDA Review#
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