HYDROCOLLOID TRAY MATERIALS, MED. TO HIGH VISCOSITY/WASH MATERIALS, LOW VISCOSITY
FDA 510(k) clearance K955892 · decided 1996-03-05
Clearance details
- K-number
- K955892
- Device name
- HYDROCOLLOID TRAY MATERIALS, MED. TO HIGH VISCOSITY/WASH MATERIALS, LOW VISCOSITY
- Applicant
- Van R Dental Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-12-28
- Decision date
- 1996-03-05
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- ELW
- Device class
- 2
- Regulation number
- 872.3660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Oxnard, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.