510(k) K212533
- Device
- BLX WB Ø5.0 (L18), Ø5.5 And Ø6.5 Mm (L14 And L16) Implants
- Applicant
- Institut Straumann AG
- 510(k) number
- K212533
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2022-01-28
- Date received
- 2021-08-11
- 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
Applicant Contact#
- Contact
- Corinne Arimatea
- Address
- Peter Merian Weg 12 Basel CH CH-4002 CH-4002
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#
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 |
| K252168 | Straumann® BLC Implants - Indication Widening | Institut Straumann AG | 2026-03-10 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases