510(k) K071353
- Device
- FOSHION CHAIR MOUNTED DENTAL, MODEL FJ48C
- Applicant
- SHANGHAI FOSHION MEDICAL INSTRUMENTS CO., LTD.
- 510(k) number
- K071353
- Product code
- KLC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-12-14
- Date received
- 2007-05-15
- Regulation
- 872.6250
- Classification name
- Chair, Dental, With Operative Unit
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- WILLIAM MCLAIN
- Address
- 342 E Main St., Suite 211 #3 Rd. Leola PA US 17540 17540
FDA Registration Numbers#
- 3029780
- 3042256511
- 3039246551
- 3031886796
- 3015980207
- 3002819275
- 3009598746
- 3021741513
- 3033509587
- 3006191485
- 3008770655
- 3010373494
- 3013237609
Source Documents#
Other 510(k) Records For Product Code KLC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233921 | Luvis Chair (LC700C) | Dentis Co., Ltd. | 2024-09-06 |
| K151987 | DCI Edge Dental Chair with Operative Unit | Dci | 2016-06-01 |
| K971063 | OPTIMA PLUS E DENTAL CHAIR; A DENTAL CHAIR; EXCEL CHAIR | King Dental Corp. | 1997-06-03 |
| K963209 | PROSTYLE COMPACT | Planmeca Oy | 1996-10-24 |
| K942870 | ULTIMA 2 DENTAL CHAIR | Dentech Corp. | 1995-02-27 |
| K940950 | KAVO SYSTEMATICA 1060 | Kavo America | 1994-12-29 |
| K925567 | E 4000 DENTAL OPERATING CHAIR | Dentalez Group | 1994-03-10 |
| K923534 | PM2002 PROLINE | Planmeca USA, Inc. | 1994-01-31 |
| K925119 | A-DEC 1040 CHAIR | A-Dec, Inc. | 1994-01-31 |
| K925319 | A-DEC 2182 DOCTOR'S UNIT | A-Dec, Inc. | 1993-12-09 |
| K925314 | A-DEC 2170 DUO UNIT CUSP | A-Dec, Inc. | 1993-12-09 |
| K925315 | A-DEC 2171 DUO UNIT | A-Dec, Inc. | 1993-12-09 |
| K925316 | A-DEC 2172 DOCTOR'S UNIT | A-Dec, Inc. | 1993-12-09 |
| K925317 | A-DEC 2180 DUO UNIT, CUSP | A-Dec, Inc. | 1993-12-09 |
| K925318 | A-DEC 2181 DUO UNIT | A-Dec, Inc. | 1993-12-09 |
Legacy Summary#
summary
FDA Review#
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