EASY X-TRAC SYSTEM
FDA 510(k) clearance K060691 · decided 2006-06-12
Clearance details
- K-number
- K060691
- Device name
- EASY X-TRAC SYSTEM
- Applicant
- A. Titan Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-03-15
- Decision date
- 2006-06-12
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- EMG
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Hamburg, NY, 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 |
|---|---|---|
| MEISINGER BENEX, MODEL BE001 (K062130) | Hager& Meisinger GmbH | 2007-04-16 |
| 500/1 TO 500/80 VARIOUS TYPES OF ENGLISH PAT DENTA (K851708) | Artiberia | 1985-07-01 |
| 560 TO 577 VARIOUS TYPES OF FORCEPS FOR CHILDREN (K851709) | Artiberia | 1985-06-11 |
| 600/203 TO 650/74XN VARIOUS TYPES OF DENT EXTRACTI (K851712) | Artiberia | 1985-06-11 |
| 600/7 TO 600/288 VARIOUS TYPES OF AMER. PATTERN DE (K851711) | Artiberia | 1985-06-11 |
| TOOTH EXTRACTING FORCEPS 151(2010)-875 PCS. SS410/ (K851105) | The Huxley Instrument Corp. | 1985-05-15 |
| CAT. 8 DENTAL DEVICES (K840312) | Imm Enterprises , Ltd. | 1984-04-05 |
| DENTAL INSTRUMENTS - SURGICAL FORCEPS (K823325) | Miltex, Inc. | 1982-11-24 |
| BEACH FORCEP NO. 150 AND NO. 151 (K821781) | Pacific Dental Corp. | 1982-07-02 |
Recalls involving this device
No recalls on record reference this clearance.