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
Applicant Contact#
- Contact
- Mateusz Leszczak
- Address
- 85 Ben Fairless Dr. Fariless Hills PA US 19030 19030
FDA Registration Numbers#
- 3008770646
- 3008932779
- 3017064961
- 3011587630
- 3031303433
- 9611993
- 9681851
- 3012187973
- 3009217531
- 3015456817
- 3011390931
- 3005497913
- 3002963873
- 3004860162
- 3006540014
- 3004036186
- 3014270094
- 3014290448
- 3032802037
- 3006948427
- 3018097239
- 8010516
- 1223843
- 3005115116
- 3035532394
- 3006473685
- 3011461101
- 3017548645
- 9614404
- 3011575197
- 3018501314
- 3030039110
- 3012354669
- 3010178296
- 3033519161
- 3021076825
- 1450662
- 3014142650
- 3023878501
- 3005409899
- 3009514134
- 1038806
- 8043792
- 3004556094
- 3014112268
- 3008309654
- 3024858450
- 3004417597
- 3013562441
- 3007740664
- 3011656326
- 3009528809
- 3008496301
- 8044131
- 3032439351
- 9617542
- 3027665899
- 3003402534
- 3006948193
- 3008812251
- 3004884150
- 3012121192
- 3004883837
- 3013527433
- 3026365523
- 3014329459
- 9680605
- 3024185724
- 3009756327
- 3017125693
- 2029275
- 3014107733
- 3003847101
- 3027595870
- 3003394627
- 3001295407
- 3031162123
- 3002807112
- 3030089802
Source Documents#
Other 510(k) Records For Product Code NHA#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261327 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2026-09-30 |
| K262207 | Cemented Plus Abutment | Unidental Co., Ltd. | 2026-09-23 |
| K260940 | BellaTek Bars | ZimVie US Corp, LLC | 2026-09-21 |
| K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw | Nobel Biocare AB | 2026-08-06 |
| K261147 | Neodent Implant System - NeoConvert Fit | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-07-01 |
| K261122 | MIST IC | Imagine Milling Technologies, LLC | 2026-06-27 |
| K260061 | BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. | 2026-06-26 |
| K253922 | Neodent Scannable Healing Abutment | JJGC Indústria e Comércio de Materiais Dentários S.A. | 2026-06-15 |
| K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) | Smart Denture Conversions, LLC | 2026-06-11 |
| K260564 | DESS Dental Smart Solutions | Terrats Medical SL | 2026-06-09 |
| K252904 | SIC Abutments including CAD/CAM Solutions | Sic Invent AG | 2026-06-03 |
| K253774 | Elos Accurate® Denture Fixation System | Elos Medtech Pinol A/S | 2026-05-20 |
| 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 |