CYBERJET LOCAL ANESTHESIA SYSTEM
FDA 510(k) clearance K964802 · decided 1997-05-27
Clearance details
- K-number
- K964802
- Device name
- CYBERJET LOCAL ANESTHESIA SYSTEM
- Applicant
- Intra Vantage, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-11-29
- Decision date
- 1997-05-27
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- EGM
- Device class
- 2
- Regulation number
- 872.4475
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Concord, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Intra Vantage
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| QuickSleeper 5 (K243427) | Dentalhitec | 2025-08-01 |
| W&H HANDPIECE ANESTO, MODEL: RA-5 (K083811) | W&H Dentalwerk Buermoos GmbH | 2010-01-14 |
| HYPODERMIC JET INJECTION APPARATUS (K962017) | American Jet Injector Corp. | 1996-07-26 |
| PAROJECT ANESTHETIC SYRINGE (K904279) | Ronvig Instruments, Ltd. | 1990-12-07 |
| HENKE-JECT PRESSURE SYRINGE (MODIFICATION) (K864294) | Smith & Nephew, Inc. | 1987-11-04 |
| GRADTECH SYRINGE SYSTEM (K864732) | Gradtech | 1987-04-15 |
| INSTRUMENTATIONS UNLIMITED SYRINGE SYSTEM (K864861) | Instrumentations Unltd. | 1987-02-13 |
| JSB JET SYRINGE (K834361) | C.B.S. Biotechnics, Inc. | 1984-03-05 |
| MAYO SCISSOR STRAIGHT 6 3/4 (K821273) | Conphar, Inc. | 1982-05-28 |
| MIZZY SYRIJET MARK IV (K790193) | Mizzy, Inc. | 1979-04-23 |
Recalls involving this device
No recalls on record reference this clearance.