510(k) K181932
- Device
- DTX Studio Design
- Applicant
- Nobel Biocare AB
- 510(k) number
- K181932
- Product code
- PNP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-03-01
- Date received
- 2018-07-19
- Regulation
- 872.3630
- Classification name
- Dental Abutment Design Software For Dental Laboratory
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Charlemagne Chua
- Address
- Box 5190, Se-402 26, Vastra Hamngatan 1 Goteborg SE SE-411 17 SE-411 17
FDA Registration Numbers#
- 3014118611
- 2027971
- 3011649314
- 3004884150
- 2918719
- 9611993
- 3005512166
- 3013718526
- 9681199
- 1222315
- 3004860162
- 3013343038
- 3015456817
- 3019252621
- 9614404
- 3003310824
- 3006473685
- 3011824442
- 9612352
- 3003394627
- 3033781108
- 3005952241
- 3012690648
- 3005383085
- 1060818
- 9611992
- 3004966444
- 3005739655
- 3007689689
- 3016954909
- 3006945044
- 3024185724
- 3029915447
- 3008870565
- 3008693672
- 3030255892
- 8020776
- 3013111692
- 3009795022
- 3010596333
- 3010728558
- 3005497913
- 3008770646
- 3007518363
- 3026444199
- 9613348
- 3009756327
- 3009496224
- 3001617766
- 3004203816
- 3011521456
- 3008261720
- 9614977
- 3005031178
- 3005940400
- 3006540014
Source Documents#
Other 510(k) Records For Product Code PNP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233252 | Straumann CARES Visual and Nova Dental CAD | Institut Straumann AG | 2024-12-26 |
| K231529 | CloudPoint FastDesign Chairside | Prismatik Dentalcraft, Inc. | 2024-03-14 |
| K221107 | TRUST | Rgorithm Korea | 2023-07-18 |
| K193352 | AbutmentCAD | Exocad GmbH | 2021-07-21 |
| K200100 | Abutment Design | 3Shape A/S | 2020-10-07 |
| K200191 | Sirona Dental CAD/CAM System with InLab Software | Dentsply Sirona | 2020-08-19 |
| K151455 | 3Shape Abutment Designer Software | 3Shape A/S | 2016-09-06 |
Legacy Summary#
summary