510(k) K123784
- Device
- STRAUMANN DENTAL IMPLANT SYSTEM
- Applicant
- STRAUMANN USA, LLC
- 510(k) number
- K123784
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-04-10
- Date received
- 2012-12-10
- 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
- No
Applicant Contact#
- Contact
- JENNIFER M JACKSON, MS
- Address
- 60 Minuteman Rd. Andover MA US 01810 01810
FDA Registration Numbers#
- 3004201263
- 3007518363
- 3010392243
- 3010730876
- 3004730368
- 1526534
- 1030489
- 3047516639
- 3010948854
- 8010177
- 3009847764
- 3013547803
- 1410097
- 2219920
- 3016447764
- 1220477
- 3006411780
- 3009632672
- 3017399129
- 1000244346
- 9681851
- 3011587077
- 8043971
- 3009201148
- 3007135442
- 3033708818
- 3010287685
- 1450662
- 2023623
- 3010596333
- 3009611645
- 3008388248
- 3014596751
- 9617542
- 3008910197
- 3015218457
- 3001082453
- 3016099073
- 2027062
- 9611992
- 3011545243
- 3012106319
- 3024858450
- 1824199
- 1424263
- 3008770646
- 9680963
- 3005031178
- 3042272797
- 3007842672
- 1054811
- 1036836
- 3038718579
- 3003781339
- 2087259
- 3002807050
- 3013376795
- 2027754
- 3005115116
- 3005941719
- 3042971970
- 2085360
- 3008261720
- 3007515069
- 3006034256
- 3017125693
- 3038549074
- 2183828
- 3005121682
- 3017013344
- 3009325911
- 3005914490
- 3013271380
- 9613662
- 3005216725
- 3001110146
- 3018077122
- 3002963873
- 3032163716
- 3012422333
Source Documents#
Other 510(k) Records For Product Code DZE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260463 | ZEROS Dental Implant System | Zeros Co., Ltd. | 2026-08-19 |
| K251188 | UNIQA® Dental Implants System | Uniqa Dental, Ltd. | 2026-06-25 |
| K250806 | Dental Implant System | A.B. Dental Devices , Ltd. | 2026-06-18 |
| K251232 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | 2026-06-18 |
| K260006 | INOSS System | Inosys, Inc. | 2026-06-17 |
| 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 |
| K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | 2025-12-23 |
| K252145 | GEN5™ and GEN5+™ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC | 2025-12-23 |
Legacy Summary#
summary
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