510(k) K891186
- Device
- REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT
- Applicant
- BENN RESEARCH LTD.
- 510(k) number
- K891186
- Product code
- EHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-04-12
- Date received
- 1989-03-06
- Regulation
- 872.1820
- Classification name
- Aligner, Beam, X-ray
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DOUGLAS K BENN
- Address
- 2 Pangbourne Dr. Stanmore, Middlesex GB HA7 4QT HA7 4QT
FDA Registration Numbers#
- 3009171220
- 3014131436
- 2431224
- 3010656982
- 3004623350
- 1722021
- 8043962
- 3015276580
- 1036212
- 3015729
- 2024949
- 2086043
- 3008361230
- 3021551875
- 2424472
- 3004082121
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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