MAXCEM 2
FDA 510(k) clearance K073209 · decided 2008-01-29
Clearance details
- K-number
- K073209
- Device name
- MAXCEM 2
- Applicant
- Kerr Corporation
- Decision
- Substantially Equivalent
- Date received
- 2007-11-14
- Decision date
- 2008-01-29
- Days to decision
- 76 days
- Clearance type
- Traditional
- Product code
- MZW
- Device class
- 2
- Regulation number
- 872.3275
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Orange, CA, 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 |
|---|---|---|
| SOOTHE-N-SEAL CANKER SORE RELIEF (K991923) | Closure Medical Corp. | 1999-09-02 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Kerr Maxcem Elite, self-etch/self-adhesive resin cement; Intro Kit Part No. 34417; DMC 044 recall (Z-1076-2013) | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical | 2013-04-10 |
| Brand name: Maxcem Elite, Product: a dental cement, Part Number: 34418. The intended use o recall (Z-0915-2012) | Kerr Corporation | 2012-01-27 |
| Maxcem Elite(TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g, REF/Part recall (Z-0390-2012) | Henry Schein, Inc. | 2012-01-11 |