510(k) K170838
- Device
- Medentika CAD/CAM TiBases
- Applicant
- Medentika GmbH
- 510(k) number
- K170838
- Product code
- NHA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-09-15
- Date received
- 2017-03-21
- 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
- No
Applicant Contact#
- Contact
- Gerhard Polzer
- Address
- Ahammweg 8-10 Huegelsheim DE 76549 76549
FDA Registration Numbers#
- 3004201263
- 3007518363
- 3010392243
- 3010730876
- 3004730368
- 2436986
- 3031303433
- 1526534
- 3010948854
- 3009847764
- 3013547803
- 1410097
- 2219920
- 3016447764
- 1220477
- 3005126636
- 3006411780
- 3009632672
- 3017399129
- 1000244346
- 9614977
- 9681851
- 3011587077
- 8043971
- 3009201148
- 3007135442
- 3033708818
- 3010287685
- 3009795022
- 1450662
- 3010596333
- 3009611645
- 9613953
- 3008388248
- 3014596751
- 9617542
- 3014270094
- 3008910197
- 3015218457
- 3001082453
- 3016099073
- 3015456817
- 2027062
- 9611992
- 3011545243
- 3013960456
- 3005730680
- 3007740664
- 3009551666
- 3012106319
- 3024858450
- 3012354669
- 1424263
- 3008770646
- 3005031178
- 3009779268
- 3005512166
- 3007842672
- 3027595870
- 1036836
- 3014142650
- 3013551048
- 3038718579
- 3003781339
- 2087259
- 3002807050
- 3013376795
- 3013578168
- 3004370612
- 3009432160
- 3005115116
- 3005941719
- 3039397999
- 3042971970
- 3035532394
- 3008261720
- 3007515069
- 3005952241
- 9614705
- 3017125693
Source Documents#
Other 510(k) Records For Product Code NHA #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | Hiossen, Inc. | 2026-05-14 |
| 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 |
Legacy Summary#
summary
FDA Review#
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