REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT
FDA 510(k) clearance K891186 · decided 1989-04-12
Clearance details
- K-number
- K891186
- Device name
- REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT
- Applicant
- Benn Research , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-06
- Decision date
- 1989-04-12
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- EHA
- Device class
- 1
- Regulation number
- 872.1820
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Stanmore, Middlesex, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.