BI-CENTRIC SYSTEM
FDA 510(k) clearance K760404 · decided 1976-08-23
Clearance details
- K-number
- K760404
- Device name
- BI-CENTRIC SYSTEM
- Applicant
- Pelton & Crane Co.
- Decision
- Substantially Equivalent
- Date received
- 1976-08-09
- Decision date
- 1976-08-23
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- KLC
- Device class
- 1
- Regulation number
- 872.6250
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR (K971063) | King Dental Corp. | 1997-06-03 |
| PROSTYLE COMPACT (K963209) | Planmeca Oy | 1996-10-24 |
| ULTIMA 2 DENTAL CHAIR (K942870) | Dentech Corp. | 1995-02-27 |
| KAVO SYSTEMATICA 1060 (K940950) | Kavo America | 1994-12-29 |
| E 4000 DENTAL OPERATING CHAIR (K925567) | Dentalez Group | 1994-03-10 |
| A-DEC 1040 CHAIR (K925119) | A-Dec, Inc. | 1994-01-31 |
| PM2002 PROLINE (K923534) | Planmeca USA, Inc. | 1994-01-31 |
| A-DEC 2185 DOCTOR'S UNIT (K925325) | A-Dec, Inc. | 1993-12-09 |
| A-DEC 2183 DUO UNIT, CUSP (K925323) | A-Dec, Inc. | 1993-12-09 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Pelton & Crane Dental Chairs, Chairman 5000 with magnetic headrest, Pelton & Crane, Charlo recall (Z-1179-2010) | Pelton & Crane Company | 2010-04-01 |
| Pelton & Crane Dental Chairs, Spirit 1500 with magnetic headrest, Pelton & Crane, Charlott recall (Z-1180-2010) | Pelton & Crane Company | 2010-04-01 |
| Pelton & Crane Dental Chairs, Spirit 1800 with magnetic headrest, Pelton & Crane, Charlott recall (Z-1324-2010) | Pelton & Crane Company | 2010-04-01 |
| Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest, Pelton & Crane, Charlott recall (Z-1325-2010) | Pelton & Crane Company | 2010-04-01 |
| Pelton & Crane Dental Chairs, Spirit 3000 with magnetic headrest, Pelton & Crane, Charlott recall (Z-1326-2010) | Pelton & Crane Company | 2010-04-01 |