510(k) K253372
- Device
- ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments
- Applicant
- Hiossen, Inc.
- 510(k) number
- K253372
- Product code
- NHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-14
- Date received
- 2025-09-30
- Regulation
- 872.3630
- Classification name
- Abutment, Implant, Dental, Endosseous
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Mateusz Leszczak
- Address
- 85 Ben Fairless Dr. Fariless Hills PA US 19030 19030
FDA Registration Numbers
- 1450662
- 3031025053
- 1222315
- 9612300
- 3006473685
- 2027062
- 2183744
- 3012172055
- 3023852420
- 3016447764
- 3008770646
- 3005290844
- 3004966444
- 3014142650
- 3007842672
- 3012422333
- 3014118611
- 3002807112
- 3013111692
- 1038806
- 3021964955
- 3005674514
- 3030690317
- 2918719
- 3007728094
- 3010303805
- 3024858450
- 3009528809
- 9614705
- 3009756327
- 3030488649
- 3003618527
- 3011221537
- 3024852742
- 3009761487
- 3009847764
- 3004417597
- 1000244346
- 3004198398
- 3001082453
- 3009632672
- 3013547803
- 3005663340
- 8010591
- 1222802
- 3033708818
- 3004883837
- 3009528826
- 3035532393
- 3008870565
- 3005512166
- 3013102320
- 3006592743
- 3014596751
- 3019793783
- 3007740664
- 1054986
- 3017833095
- 9614404
- 9612352
- 3008186372
- 3010287685
- 3004578807
- 3009727738
- 3008252251
- 3013960655
- 3036779616
- 3007515069
- 3006017180
- 3023535580
- 3013701115
- 3014938434
- 1627417
- 3010393542
- 2029275
- 1221541
- 9680605
- 3012481042
- 3005739655
Source Documents
Other 510(k) Records For Product Code NHA
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | Institut Straumann AG | 2026-05-07 |
| K253804 | DESS Dental Smart Solutions | Terrats Medical SL | 2026-04-16 |
| K260555 | LOCATOR® Angled Abutment | Zest Anchors, LLC | 2026-04-09 |
| K251434 | Healing Abutment System | Osstem Implant Co., Ltd. | 2026-03-04 |
| K251515 | Solidex® Ti-Links and Screws | CreoDent Hudson Valley | 2026-02-10 |
| K251427 | EK MULTI ANGLED 30 ABUTMENT | Hiossen, Inc. | 2026-01-29 |
| K243732 | Multi-Unit DAS System | Talladium España, SL | 2026-01-29 |
| K253315 | Straumann Variobase Abutments XC for Bridge/Bar | Institut Straumann AG | 2026-01-22 |
| K253253 | IPDmilled Blanks | Implant Protesis Dental 2004, S.L. | 2026-01-22 |
| K252727 | Neodent InLab Validated Workflow | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-01-07 |
| K253341 | Custom Abutments AS | Medentika GmbH | 2025-12-23 |
| K253312 | OrangeCAD Med Abutments | Orangecad Med GmbH | 2025-12-23 |
| K252320 | SIMDA Abutments | Simda Co., Ltd. | 2025-12-18 |
| K252343 | Atlantis® Abutments in Titanium | Dentsply Sirona | 2025-12-09 |
| K252248 | CEREC Tessera Abutment System | Dentsply Sirona | 2025-11-26 |