510(k) K060691
- Device
- EASY X-TRAC SYSTEM
- Applicant
- A. TITAN INSTRUMENTS, INC.
- 510(k) number
- K060691
- Product code
- EMG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-06-12
- Date received
- 2006-03-15
- Regulation
- 872.4565
- Classification name
- Forceps, Tooth Extractor, Surgical
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL TUBER
- Address
- 97 Main St. Hamburg NY US 14075 14075
FDA Registration Numbers#
- 3013552516
- 3006487092
- 3034278341
- 9614986
- 9614069
- 8010769
- 9610612
- 3015422158
- 2032006
- 3014334038
- 8010704
- 3010442693
- 3008711893
- 8040884
- 9616250
- 2431166
- 3005809810
- 8043752
- 3008346537
- 8010159
- 3036795921
- 9680518
- 3005067367
- 3043625057
- 3009968482
- 3009049852
- 1421101
- 3015895045
- 8010516
- 3004608878
- 3004992978
- 3024988980
- 3001644167
- 3002808270
- 9611278
- 9680260
- 3009703496
- 3014314985
- 3017367014
- 3003882399
- 2246990
- 1032347
- 3003759558
- 8010372
- 5906
- 9710524
- 8021788
- 3011371465
- 1923569
- 8040179
- 3009171220
- 3010455030
- 3002675176
- 3010055973
- 2511556
- 4488
- 3014937043
- 3014908171
- 3013496867
- 8043622
- 9611503
- 3038718579
- 3000286616
- 3015337428
- 9613083
- 3016825318
- 1720747
- 3035708926
- 3008797953
- 3001146947
- 3018097421
- 3002807115
- 3009496321
- 8030607
- 1416605
- 8040881
- 3005621335
- 3002761766
- 3009513193
Source Documents#
Other 510(k) Records For Product Code EMG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K062130 | MEISINGER BENEX, MODEL BE001 | Hager& Meisinger GmbH | 2007-04-16 |
| K851708 | 500/1 TO 500/80 VARIOUS TYPES OF ENGLISH PAT DENTA | Artiberia | 1985-07-01 |
| K851709 | 560 TO 577 VARIOUS TYPES OF FORCEPS FOR CHILDREN | Artiberia | 1985-06-11 |
| K851711 | 600/7 TO 600/288 VARIOUS TYPES OF AMER. PATTERN DE | Artiberia | 1985-06-11 |
| K851712 | 600/203 TO 650/74XN VARIOUS TYPES OF DENT EXTRACTI | Artiberia | 1985-06-11 |
| K851105 | TOOTH EXTRACTING FORCEPS 151(2010)-875 PCS. SS410/ | The Huxley Instrument Corp. | 1985-05-15 |
| K840312 | CAT. 8 DENTAL DEVICES | Imm Enterprises , Ltd. | 1984-04-05 |
| K823325 | DENTAL INSTRUMENTS - SURGICAL FORCEPS | Miltex, Inc. | 1982-11-24 |
| K821781 | BEACH FORCEP NO. 150 AND NO. 151 | Pacific Dental Corp. | 1982-07-02 |
Legacy Summary#
summary
FDA Review#
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