510(k) K884845
- Device
- STERI-OSS
- Applicant
- DENAR CORP.
- 510(k) number
- K884845
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-02-10
- Date received
- 1988-11-21
- Regulation
- 872.3640
- Classification name
- Implant, Endosseous, Root-form
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVE HURSON
- Address
- 901 E. Cerritos Ave. Anaheim CA US 92805 92805
FDA Registration Numbers#
- 1226544
- 3023265483
- 9613866
- 3007156625
- 3011587630
- 1038806
- 1424785
- 3012635238
- 3001561923
- 9613283
- 3005031178
- 3007283751
- 3011808221
- 3023535580
- 3012187973
- 3036779616
- 3004417597
- 8031058
- 3030690317
- 3009756327
- 3007597023
- 1036836
- 3008088588
- 3006034256
- 3007135442
- 3009727738
- 3018077122
- 3005554774
- 3017840051
- 3003402534
- 2133778
- 2530808
- 3005503242
- 3011649314
- 3010303805
- 3009514134
- 3003394627
- 8044131
- 3002807050
- 3011461101
- 3016447764
- 3010363503
- 3014329459
- 3033781108
- 3038549074
- 3010407203
- 3009611645
- 3014938434
- 3010287729
- 3010876315
- 3004443656
- 3008102042
- 3008791302
- 3018662547
- 3014112268
- 2029275
- 3005121682
- 3021630667
- 3008693672
- 1223843
- 3003394081
- 1424263
- 3011936113
- 3011221537
- 3047516639
- 8010516
- 9680963
- 3008793310
- 3006948193
- 2219920
- 3003847101
- 8010177
- 3010032042
- 3007923096
- 3007366413
- 3002963873
- 9680605
- 3012106319
- 3033708818
- 3006001176
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DZE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261295 | MultiNeO Dental Implant System | Alpha Bio Tec , Ltd. | 2026-10-22 |
| K261392 | TriActive Dental Implant System | Paragon Implant Mfg., LLC | 2026-09-17 |
| 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 |
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