510(k) K962844
- Device
- REPLACE TPS COATED IMPLANTS
- Applicant
- STERI-OSS, INC.
- 510(k) number
- K962844
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-10-18
- Date received
- 1996-07-22
- 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
- PAUL GASSER
- Address
- 22895 Eastpark Dr. Yorba Linda CA US 92887 92887
FDA Registration Numbers#
- 3004203816
- 3010287729
- 3017125693
- 3011390931
- 1627417
- 3017840051
- 2133778
- 1423662
- 3033519161
- 3008309654
- 3012187973
- 3004730368
- 3017980266
- 3009325911
- 3009840806
- 3012422333
- 3036190511
- 3006034256
- 3026365523
- 3010876315
- 3005409899
- 9613348
- 8010516
- 3017548645
- 1032347
- 3007156625
- 3010303805
- 1036836
- 3005115116
- 3009528826
- 3008693672
- 3005216725
- 3004711948
- 9611253
- 3043585140
- 2183828
- 3006411780
- 3004049923
- 3030089802
- 1222802
- 2918719
- 2183744
- 3010363503
- 3013701115
- 3016447764
- 3004443656
- 3010948854
- 3024858450
- 3024852742
- 3008186372
- 3009196578
- 3015160953
- 3024859204
- 1410097
- 3015218457
- 3040978916
- 3013264549
- 3008910197
- 3010287685
- 2921595
- 3014938434
- 3026444199
- 3009847764
- 3033524692
- 2219920
- 8044131
- 3008261720
- 3033781108
- 3031886796
- 3008496301
- 1054811
- 1054986
- 3021630667
- 2029275
- 3015978392
- 9617078
- 1038806
- 3018077122
- 3005728057
Source Documents#
Other 510(k) Records For Product Code DZE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K251605 | DIMPLO Implant System | DIMPLO, Ltd. | 2025-12-22 |
Legacy Summary#
summary
FDA Review#
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