PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT
FDA 510(k) clearance K082560 · decided 2008-09-08
Clearance details
- K-number
- K082560
- Device name
- PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT
- Applicant
- Kettenbach GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2008-09-04
- Decision date
- 2008-09-08
- Days to decision
- 4 days
- Clearance type
- Traditional
- Product code
- ELW
- Device class
- 2
- Regulation number
- 872.3660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- D-35713 Eschenburg, DE
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.