510(k) K230592
- Device
- LuxCreo Dental Night Guard Resin
- Applicant
- LuxCreo, Inc.
- 510(k) number
- K230592
- Product code
- MQC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-01-18
- Date received
- 2023-03-03
- Classification name
- Mouthguard, Prescription
- Medical specialty
- Unknown
- Review panel
- Unknown
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact
- Contact
- Mike Yang
- Address
- 940 Old County Rd. Belmont CA US 94002 94002
FDA Registration Numbers
- 3002789526
- 3001389926
- 3005942449
- 2916735
- 3001295407
- 3020093493
- 3013652641
- 3011532731
- 3010279788
- 3012389497
- 3021381014
- 3009727738
- 3030515618
- 3017567754
- 2086043
- 9680954
- 3009482106
- 8030452
- 3014888923
- 2081322
- 3017520337
- 8044058
- 3015547648
- 3014270094
- 1723435
- 3022315836
- 3024749697
- 3004884150
- 3011429437
- 2032807
- 8010908
- 3009779268
- 3009815428
- 3015491441
- 3017575849
- 3003794907
- 1036212
- 3025434480
- 1043617
- 3006523393
- 3010002722
- 3004491043
- 2515379
- 3018783197
- 3022068322
- 3008347275
- 3016237718
- 3009440973
- 3012623144
- 3013343038
- 3013551048
- 3014289665
- 2280629
- 1415367
- 8010662
- 9614977
- 3005598536
- 3027494823
- 3020749939
- 1719513
- 2433919
- 1316408
- 3043044356
- 3030686055
- 2032273
- 3005350578
- 3021024355
- 3030268763
- 3005904906
- 1483306
- 3005730680
- 3009432160
- 3011649314
- 3005343849
- 3009133124
- 3039359767
- 3008320092
- 3004086252
- 3005940400
- 2523320
Source Documents
510(k) summary PDF not indicated by FDA
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|
| 00860010425497 | LuxCreo DentalNight Guard Resin | Luxcreo Inc | 2024-04-09 |
| 00860010425480 | LuxCreo DentalNight Guard Resin | Luxcreo Inc | 2024-04-09 |
| 00860010425473 | LuxCreo DentalNight Guard Resin | Luxcreo Inc | 2024-04-09 |
Other 510(k) Records For Product Code MQC
| 510(k) | Device | Applicant | Decision date |
|---|
| K253798 | UltraPrint-Dental Hard Splint UV | Guangzhou Heygears IMC., Inc. | 2026-03-02 |
| K250743 | Remvia NightGuard | Remvia | 2025-12-05 |
| K251252 | NOBILCAM IMPAK Disc | Shandong Huge Dental Material Corporation | 2025-08-01 |
| K241729 | Hard Splint & Thermo-Adaptive Splint | Whip Mix Corporation | 2025-03-18 |
| K243516 | Remi Custom Night Guard | Grindguard, Inc. | 2025-02-10 |
| K241369 | LIJIA Night Guard | Lijia, LLC | 2024-08-22 |
| K231775 | GR Resin System MSI | Pro3Dure Medical | 2024-08-08 |
| K241311 | Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach) | Bernhard Förster GmbH | 2024-08-02 |
| K240463 | Slow Wave DS8 (SWDS802) | Slow Wave, Inc. | 2024-06-04 |
| K231793 | RODIN 3D Resin SPLINT, Hard/Flex | Belport Company, Inc., Gingi-Pak | 2024-03-26 |
| K232087 | Dental LT Comfort Resin | Formlabs Ohio, Inc. | 2024-02-16 |
| K230548 | Myoaligner Appliance | Myohealth Technologies, LLC | 2024-02-02 |
| K222845 | Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece | Frey Oral Technologies, LLC | 2023-11-28 |
| K230495 | Serena Sleep Night Guard | Meris Investment Group | 2023-10-13 |
| K232448 | FREEPRINT® splintmaster | Detax GmbH | 2023-10-12 |