510(k) K252168
- Device
- Straumann® BLC Implants - Indication Widening
- Applicant
- Institut Straumann AG
- 510(k) number
- K252168
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-10
- Date received
- 2025-07-10
- 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
- N
Related Records
Applicant Contact
- Contact
- Jose Vitor Araujo
- Address
- Peter Merian-Weg 12 Basel CH CH-4002 CH-4002
FDA Registration Numbers
- 1450662
- 9612300
- 3036190511
- 2027062
- 2183744
- 3012172055
- 3023852420
- 3016447764
- 3008770646
- 3005290844
- 3007842672
- 3012422333
- 3014118611
- 3002807112
- 3030447506
- 3013111692
- 1038806
- 3030690317
- 2918719
- 3007728094
- 3010303805
- 2086964
- 3024858450
- 3009528809
- 3009756327
- 8010177
- 3016784205
- 3011221537
- 3024852742
- 3009761487
- 3009847764
- 3004417597
- 1000244346
- 3001082453
- 3009632672
- 3013547803
- 3005663340
- 8010591
- 1030489
- 1222802
- 3033708818
- 3042272797
- 3009528826
- 3008870565
- 3013102320
- 3006592743
- 3006001176
- 3010383847
- 3014596751
- 9617078
- 1054986
- 3017833095
- 9614404
- 3008186372
- 3010287685
- 3004578807
- 3009727738
- 3008252251
- 3036779616
- 3007515069
- 3006017180
- 3023535580
- 3013701115
- 3014938434
- 1032347
- 1627417
- 3010393542
- 2029275
- 3004049923
- 3004431266
- 1221541
- 9680605
- 9613662
- 3014540272
- 3009848796
- 3010876315
- 3006411780
- 8010468
- 3022316560
- 8043792
- 3009737865
- 3018094310
- 8030870
- 1423662
- 3015620565
- 9613348
- 3011936113
- 3011276344
- 9613866
- 3006948427
- 3010251542
- 1000461041
- 3008886124
- 3007283751
- 2032098
- 3000203391
- 3003781339
- 1718476
- 3017548645
- 2027754
- 3010162973
- 2023950
- 3014112268
- 3015160953
- 2024024
- 3008959419
- 3007923096
- 3027665899
- 9680963
- 3017980266
- 1223843
- 2087481
- 2087259
- 3038549074
- 3002807310
- 9680939
- 3009161350
- 3003847101
- 3004638532
- 3012635238
- 3008791302
- 3003402534
- 1825034
- 3006110126
- 3011587630
- 1424785
- 2245590
- 3007135442
- 3014290448
- 3010160527
- 9611253
- 3004730368
- 3013271380
- 3010705004
- 3017064961
- 3029820793
- 3012465917
- 1226544
- 1054811
- 3031493119
- 3009196578
- 8010516
- 3003236702
- 3015527825
- 3009514134
- 3003394627
- 3015218457
- 3011656326
- 3011187779
- 8044131
- 3015383403
- 3008088588
- 3013167159
- 3003394081
- 2031884
- 2022435
- 3010363503
- 1424263
- 3007218081
- 1723412
- 2523430
- 3006034256
- 1057946
- 3008496301
- 3012106319
- 3009840806
- 3010610960
- 3008910197
- 3011461101
- 3012187973
- 3031529635
- 3005121682
- 1036836
- 3042971970
- 3008791019
- 3011649314
- 3042227762
- 2029005
- 3013034344
- 3033781108
- 3001561923
- 3014329459
- 3012121192
- 3008309654
- 3005554774
- 3013173272
- 3007649394
- 3024185724
- 3006540014
- 3011824442
- 3009217531
- 3008494722
- 3017399129
- 9613283
- 3002963873
- 1410097
- 3010596333
- 3020144887
- 3016099073
- 3017013344
- 1526534
- 2921595
- 3008808095
- 3014843857
- 3002808227
- 9610905
- 3005497913
- 3008102042
- 3005941719
- 3004201263
- 1000577893
- 3025517712
- 2133778
- 3005914490
- 3011545243
- 3033524692
- 2183828
- 3008252900
- 3026444199
- 3003184527
- 3004443656
- 9611992
- 3005728057
- 3011575197
- 3001295407
- 3031553803
- 3002807050
- 3007689689
- 3010178296
- 3032163716
- 9612468
- 3026365523
- 3007126709
- 3005998060
- 3008812251
- 3005115116
- 3018662547
- 3008261720
- 3005031178
- 3027494823
- 3005216725
- 2023623
- 3018097239
- 3018077122
- 3004036186
- 3011587077
- 2530808
- 3023265483
- 3001617766
- 3007031098
- 1824199
- 3005643710
- 3035820532
- 3014129047
- 3015775866
- 3011891801
- 9617542
- 3010948854
- 3007529467
- 3001110146
- 8010099
- 3032439351
- 1060818
- 8020776
- 8031058
- 3009611645
- 3008793310
- 3008388248
- 3005409899
- 3004711948
- 1649518
- 3011808221
- 3010032042
- 3009201148
- 3010392243
- 2249649
- 3010287729
- 3013264549
- 3025338240
- 9611993
- 3016172557
- 3015978392
- 3003477135
- 2245304
- 3004203816
- 9681851
- 3013376795
- 3007156625
- 3024859204
- 3006948193
- 3006405073
- 3010730876
- 3017125693
- 3021630667
- 3014270103
- 1220477
- 2027971
- 3017840051
- 3043585140
- 1643817
- 2219920
- 3007536957
- 3031886796
- 3005503242
- 3029973218
- 3011390931
- 3030089802
- 3007366413
- 3030039110
- 8043971
- 3006796211
- 3021076825
- 3010407203
- 3033519161
- 3011103459
- 3038136479
- 3007518363
- 2085360
- 3007597023
- 3008693672
- 3009325911
- 3016733895
Source Documents
Other 510(k) Records For Product Code DZE
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant | Promimic AB | 2026-05-12 |
| K252031 | Adin Long Dental Implant System | Adin Dental Implant Systems , Ltd. | 2026-03-23 |
| K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | 2026-03-16 |
| K253493 | Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. | 2026-03-04 |
| K252197 | Nobel Biocare S Series Implants | Nobel Biocare AB | 2026-02-18 |
| K252286 | BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. | 2026-02-02 |
| K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | 2026-01-08 |
| K252145 | GEN5 and GEN5+ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC | 2025-12-23 |
| K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | 2025-12-23 |
| K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025-12-22 |
| K252090 | Pterygoid Indication for GM Helix Implants | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2025-12-12 |
| K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | S.I.N. Implant System Ltda | 2025-11-07 |
| K251938 | GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC | 2025-10-30 |
| K243078 | HexaPLUS S OneDrill Implant System | Osseofuse International, Inc. | 2025-10-10 |
| K243983 | Paltop Dental Implant System | Paltop Advanced Dental Solutions, Ltd. | 2025-09-29 |