510(k) K090054
- Device
- ATLAS IMPLANT SYSTEM - WIDE PLUS
- Applicant
- COWELLMEDI CO., LTD
- 510(k) number
- K090054
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-07-29
- Date received
- 2009-01-08
- 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
- JUNG BAE BANG
- Address
- 13340 E Firestone Blvd. Suite J Santa Fe Springs CA US 90670 90670
FDA Registration Numbers#
- 9680605
- 3012465917
- 3025517712
- 3009761487
- 2027971
- 8010099
- 3003402534
- 3026444199
- 2087259
- 3005728057
- 3031553803
- 3042971970
- 8044131
- 3007218081
- 9611992
- 3007283751
- 3043585140
- 1649518
- 3007649394
- 3010392243
- 8043971
- 3006948193
- 2032098
- 1410097
- 8010516
- 3031886796
- 3004203816
- 3009196578
- 3008812251
- 3017013344
- 3033519161
- 3003847101
- 3027665899
- 3013376795
- 3038549074
- 3008791019
- 3038136479
- 2249649
- 3008102042
- 3009632672
- 1226544
- 3021630667
- 3017833095
- 3009201148
- 3004638532
- 2183744
- 3012172055
- 3014290448
- 9681851
- 3011656326
- 3026365523
- 3008791302
- 3002808227
- 2022435
- 3010178296
- 3007126709
- 3008910197
- 3010393542
- 3008770646
- 3010948854
- 3014329459
- 3001295407
- 9611993
- 3009161350
- 3009514134
- 3018077122
- 9612300
- 2086964
- 3009727738
- 3015775866
- 3004036186
- 9614404
- 3010287729
- 3008388248
- 3010730876
- 2024024
- 3010705004
- 3005409899
- 3009756327
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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