510(k) K872471
- Device
- Titane Sl Dental Burr
- Applicant
- TITANE SL CO.
- 510(k) number
- K872471
- Product code
- ECM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-09-11
- Date received
- 1987-06-23
- Regulation
- 872.5410
- Classification name
- Band, Preformed, Orthodontic
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- R LEITGEN
- Address
- Suite 1109 111 Marquette Ave. S. Minneapolis MN US 55401 55401
FDA Registration Numbers#
- 3026326493
- 2183301
- 3009827000
- 3008808049
- 3008317118
- 9680845
- 3005537733
- 3009491780
- 3010065389
- 3027323119
- 3003092374
- 3005728057
- 3001561923
- 3007504672
- 3004158247
- 3014425175
- 3007513373
- 3015272949
- 3038718579
- 3015259864
- 3009171220
- 3005014825
- 3012101632
- 2649784
- 3011539071
- 3011554142
- 3015337428
- 8010342
- 3009011037
- 3029917416
- 2126683
- 3016051804
- 3032027578
- 3015136927
- 3010583458
- 3004704962
- 3014683120
- 3009646973
- 3003678542
- 3010032042
- 3007616048
- 3009955691
- 3016543896
- 9611367
- 3015276158
- 3012771684
- 3006707038
- 3005505603
- 3014054179
- 3008524225
- 3027520354
- 3007010296
- 3034693059
- 3030680214
- 3034278341
- 3043149181
- 2411797
- 3043648115
- 1833132
- 3013508670
- 3006291983
- 3006237499
- 3008005217
- 3013410675
- 3003850991
- 3013561919
- 8044058
- 1000439711
- 3014270297
- 3010517827
- 3006155566
- 2081322
- 3007962015
- 3010669020
- 3011788941
- 3012715571
- 1815540
- 3032911850
- 1718476
- 2024980
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code ECM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K925163 | MICODOSE CHLORHEXIPREP | Unicep | 1993-05-27 |