THE PLACER
FDA 510(k) clearance K811582 · decided 1981-07-28
Clearance details
- K-number
- K811582
- Device name
- THE PLACER
- Applicant
- Cavitron Corp.
- Decision
- Substantially Equivalent
- Date received
- 1981-06-05
- Decision date
- 1981-07-28
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- EID
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, 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 |
|---|---|---|
| BONE GRAFT DELIVERY SYRINGES (K941431) | Bio-Interfaces, Inc. | 1994-07-12 |
| ACCESS IMPRESSION BARREL (K913974) | Centrix, Inc. | 1992-02-25 |
| CAULK'S VPS CARTRIDGE SYSTEM (K873153) | Dentsply Intl. | 1987-09-16 |
| IMPRESSION SYRINGE (K871937) | Dentsply Intl. | 1987-06-05 |
| COLTENE JET-MIXER (K863998) | Coltene, Inc. | 1986-10-30 |
| CENTRIX RIBBON TUBES (K853282) | Centrix, Inc. | 1985-08-23 |
| UNITEK DISPOSABLE IMPRESSION SYRINGE (K851386) | Unitek Corp. | 1985-04-29 |
| G-C IMPRESSION SYRINGE (K812680) | G-C Intl. Corp. | 1981-10-06 |
| PRISMA-FIL COMPULES (K812277) | Caulk Co., Div. Dentsply | 1981-09-08 |
| APPLICATOR, LEE IMPRESSION (K781977) | Lee Pharmaceuticals | 1978-12-20 |
| APPLIC SYSTEM APPLIER, ESPE (K770931) | Espe GmbH (Us) | 1977-06-03 |
| APPLIC SYSTEM ACTIVATOR, ESPE (K770941) | Espe GmbH (Us) | 1977-06-02 |
Recalls involving this device
No recalls on record reference this clearance.