510(k) K101225
- Device
- PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1
- Applicant
- PROMIMIC AB
- 510(k) number
- K101225
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-01-25
- Date received
- 2010-05-03
- Regulation
- 872.3640
- Classification name
- Implant, Endosseous, Root-form
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- KARIN BREDING
- Address
- Stena Center 1b Goteborg SE SE-412 92 SE-412 92
FDA Registration Numbers
- 3008388248
- 9617078
- 3016784205
- 3007515069
- 3005115116
- 3009611645
- 3015978392
- 3003847101
- 3009161350
- 3043585140
- 9611993
- 3017064961
- 3010251542
- 3035820532
- 3012187973
- 3009196578
- 3042227762
- 3009514134
- 2245304
- 3011936113
- 3002807050
- 3017833095
- 3017980266
- 3009756327
- 1032347
- 1220477
- 3009528809
- 3010160527
- 3007366413
- 3016733895
- 1060818
- 3015218457
- 3008494722
- 3024185724
- 3007842672
- 1036836
- 3004201263
- 2085360
- 3007728094
- 3004730368
- 8043971
- 3010596333
- 9680605
- 3005031178
- 1054986
- 3010948854
- 3011545243
- 3002807310
- 3008309654
- 1054811
- 2031884
- 3009217531
- 1030489
- 1424263
- 3008102042
- 9617542
- 3009632672
- 2245590
- 3008793310
- 3006411780
- 3014329459
- 8010099
- 3025517712
- 3007518363
- 1222802
- 2032098
- 2921595
- 3005554774
- 3008261720
- 3013271380
- 3014270103
- 3030447506
- 3008812251
- 3006948193
- 3008910197
- 3001110146
- 3013167159
- 3017125693
- 1038806
Source Documents
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summary
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