510(k) K023067
- Device
- IMTEC SENDAX MDI ORTHO6 AND ORTHO8
- Applicant
- IMTEC CORP.
- 510(k) number
- K023067
- Product code
- DZE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-12-03
- Date received
- 2002-09-16
- 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
- BRAD VANCE
- Address
- 2401 N Commerce Ardmore OK US 73401 73401
FDA Registration Numbers#
- 3007689689
- 3007515069
- 9610905
- 3001561923
- 3008812251
- 3013701115
- 2245304
- 3024852742
- 1000577893
- 3016733895
- 3007529467
- 1627417
- 3009201148
- 3006540014
- 3025338240
- 1718476
- 3008808095
- 3004730368
- 2085360
- 3010251542
- 3017833095
- 3027665899
- 3032834812
- 9680939
- 2087481
- 3014843857
- 3005663340
- 3014112268
- 3010705004
- 3030447506
- 3014118611
- 3021076825
- 9617542
- 3009514134
- 3007923096
- 2031884
- 3017013344
- 1226544
- 8043971
- 3003477135
- 2032098
- 3012187973
- 3013173272
- 3002807310
- 9613348
- 3007218081
- 2523430
- 3006034256
- 3004049923
- 3013111692
- 9613866
- 3025517712
- 9613283
- 3005216725
- 3008870565
- 3001110146
- 3003236702
- 3003394627
- 3005115116
- 3009840806
- 1000461041
- 3004431266
- 3002963873
- 3011656326
- 1000244346
- 3005728057
- 3032163716
- 3007597023
- 3010363503
- 1526534
- 2918719
- 1030489
- 3002808227
- 3040978916
- 3016784205
- 3043585140
- 3010160527
- 9611992
- 2022435
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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