JENKER NEEDLE STICK PROTECTOR
FDA 510(k) clearance K920758 · decided 1992-04-28
Clearance details
- K-number
- K920758
- Device name
- JENKER NEEDLE STICK PROTECTOR
- Applicant
- Dentsply Intl.
- Decision
- Substantially Equivalent
- Date received
- 1992-02-19
- Decision date
- 1992-04-28
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- DZM
- Device class
- 1
- Regulation number
- 872.4730
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- York, PA, 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 |
|---|---|---|
| X-TIP INTRAOSSEOUS PERFORATOR (K990511) | Schiff & Co. | 1999-04-27 |
| ASEPTIC DENTAL TECH. TOTAL TREATMENT SYSTEM (K914562) | Aseptic Dental Technologies, Inc. | 1992-03-09 |
| SAFETY PLUS DENTAL INJECTION NEEDLE (K913573) | Specialites Septodont | 1991-11-07 |
| DENTAL NEEDLE PROTECTIVE SYSTEM (K910475) | Health Technology Systems, Inc. | 1991-09-13 |
| STABIDENT LOCAL ANESTHESIA SYSTEM (K910446) | Fairfax Dental, Inc. | 1991-06-03 |
| SAFE-T-CAP NEEDLE COVER (K896219) | Ausmedics Pty , Ltd. | 1990-01-22 |
| NIPRO DENTAL NEEDLE (K894373) | Pharma-Plast USA, Inc. | 1989-10-13 |
| DENTAL NEEDLE (CARTRIDGE TYPE) (K870921) | Churchill Corp. | 1987-04-03 |
| TERUMO DENTAL NEEDLES (K864970) | Terumo Medical Corp. | 1987-03-10 |
| EXEL DENTAL NEEDLE (K861150) | Exel Intl. | 1986-04-11 |
| SEPTOJECT STERILE DISPOSABLE INJECTION NEEDLE (K851524) | Specialites Septodont | 1985-09-23 |
| HYPO BRAND DISPOS. DENTAL NEEDLES-PLAST (K833304) | Smith & Nephew, Mpl Division | 1984-03-30 |
Recalls involving this device
No recalls on record reference this clearance.