OTRES TOOTHBRUSH SANITIZER MODEL TB100W
FDA 510(k) clearance K003517 · decided 2001-06-06
Clearance details
- K-number
- K003517
- Device name
- OTRES TOOTHBRUSH SANITIZER MODEL TB100W
- Applicant
- Otres, LLC
- Decision
- Substantially Equivalent
- Date received
- 2000-11-14
- Decision date
- 2001-06-06
- Days to decision
- 204 days
- Clearance type
- Traditional
- Product code
- MCF
- Device class
- 1
- Regulation number
- 872.6855
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lisle, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PROSONIC ULTRAVIOLET TOOTHBRUSH SANITIZER (K023662) | Hwadong International Company , Ltd. | 2003-05-28 |
| GERM TERMINATOR GT 100 TOOTHBRUSH SANITIZER (K021258) | Germ Terminator Corporation | 2002-05-10 |
| DS60 TOOTHBRUSH SANITIZER (K901459) | Associated Mills, Inc. | 1990-09-17 |
| PUREBRUSH ULTRAVIOLET TOOTHBRUSH SANITIZER (K896481) | Purebrush Assoc. | 1990-05-15 |
Recalls involving this device
No recalls on record reference this clearance.