DELIGHT
FDA 510(k) clearance K923462 · decided 1992-12-21
Clearance details
- K-number
- K923462
- Device name
- DELIGHT
- Applicant
- Planmeca USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-07-14
- Decision date
- 1992-12-21
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- EAZ
- Device class
- 1
- Regulation number
- 872.4630
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Finland, FI
- 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 |
|---|---|---|
| MICROLUX/BLU (K072309) | Addent, Inc. | 2007-11-19 |
| MICROLUX DL (K041614) | Addent, Inc. | 2005-04-04 |
| VIZILITE-BLUE ORAL EXAM KIT (K033033) | Trylon Corp. | 2004-11-22 |
| SPECULITE/ORALLITE (K003995) | Trylon Corp. | 2001-03-16 |
| DENTAL LIGHT (K926081) | Mdt Corp., Inc. | 1994-01-26 |
| SIROLUX FANTASTIC (K935390) | Pelton & Crane Co. | 1993-12-10 |
| ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT (K925629) | Den-Tal-Ez Mfg Co., Inc. | 1993-11-23 |
| MICRONAIRE ISO-HOOD MAX 5UV (K912142) | Micronaire Corp. | 1991-10-30 |
| MINIFLEX AND PERSONAL UNIT (K912997) | Dabi-Atlante America Corp. | 1991-10-30 |
| DEFIANCE MODEL FUS 336 (K902685) | Defiance Electronics, Inc. | 1990-09-17 |
| ISOLIGHT (K894059) | Eurodent, Inc. | 1989-09-07 |
| A-DEC DENTAL LIGHT (K893044) | A-Dec, Inc. | 1989-07-14 |
Recalls involving this device
No recalls on record reference this clearance.