EXPLORER, OPERATIVE
FDA 510(k) clearance K925888 · decided 1994-02-15
Clearance details
- K-number
- K925888
- Device name
- EXPLORER, OPERATIVE
- Applicant
- Protector, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-11-16
- Decision date
- 1994-02-15
- Days to decision
- 456 days
- Clearance type
- Traditional
- Product code
- EKJ
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Long Beach, CA, 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 |
|---|---|---|
| ASEPTYLUM, UNI-CARRIER (K961714) | Distriflor S.A. | 1996-06-10 |
| MEDTROL DENTAL KIT (K953707) | Medtrol, Inc. | 1996-01-04 |
| DENTAL KIT (K945815) | Constancy Ent., Inc. | 1995-07-19 |
| SUREFLEX FILES (K951607) | Dentsply Intl. | 1995-06-22 |
| INSTRUMENT,FILLING,PLASTIC,DENTAL (K945077) | Worldwide Dental, Inc. | 1994-11-30 |
| STAT PAK (K943820) | Magnum Instruments, Inc. | 1994-11-02 |
| MAUNAL DISPOSABLE DENTAL INSTRUMENTS (K943351) | Magnum Instruments, Inc. | 1994-10-07 |
| PRESTERILIZED ENDODONTIC FILES (K943584) | Dentsply Intl. | 1994-09-21 |
| SOUTHLAND STERILE DENTAL SYSTEM (K935127) | Southland, Ltd. | 1994-07-28 |
| NON-FOGGING DENTAL MIRROR (K941954) | Buffalo Dental Mfg. Co., Inc. | 1994-07-08 |
| AMD DENTIST AND HYGIENIST KITS (K925115) | Advance Medical Designs, Inc. | 1994-07-05 |
| FORCEPS, DRESSING, DENTAL (K925889) | Protector, Inc. | 1994-02-15 |
Recalls involving this device
No recalls on record reference this clearance.