DENTATUS L SET
FDA 510(k) clearance K863016 · decided 1986-10-01
Clearance details
- K-number
- K863016
- Device name
- DENTATUS L SET
- Applicant
- Sds Dental, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-08-08
- Decision date
- 1986-10-01
- Days to decision
- 54 days
- Clearance type
- Traditional
- Product code
- KLC
- Device class
- 1
- Regulation number
- 872.6250
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, 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 |
|---|---|---|
| Luvis Chair (LC700C) (K233921) | Dentis Co., Ltd. | 2024-09-06 |
| DCI Edge Dental Chair with Operative Unit (K151987) | Dci | 2016-06-01 |
| FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C (K071353) | Shanghai Foshion Medical Instruments Co., Ltd. | 2007-12-14 |
| 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
No recalls on record reference this clearance.