Chrysalis Intelligence · Product Codes · MQC

MQC · Unclassified

35 clearances · 30 unique sponsors

Device class
Regulation —
Total clearances
35
2020-10-28 → 2026-03-02
Last 12 months
2
Unique sponsors
30
Medical specialty
Review panel
Regulation number
Implant
Life-sustain / support
GMP exempt
Third-party review
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Pro3Dure Medical GmbH 3 0 2024-08-08
Formlabs Ohio, Inc. 2 0 2024-02-16
Prismatik Dentalcraft, Inc. 2 0 2023-02-17
Envisiontec GmbH 2 0 2022-06-10
Frey Oral Technologies, LLC 1 0 2023-11-28
Lijia, LLC 1 0 2024-08-22
Ampower Dental Laboratories, LLC 1 0 2021-07-16
Erkodent Erich Kopp GmbH 1 0 2020-10-28
Slow Wave, Inc. 1 0 2024-06-04
3D Diagnostix, Inc. 1 0 2020-11-25
Panthera Dental, Inc. 1 0 2021-04-20
Belport Company, Inc., Gingi-Pak 1 0 2024-03-26
Voco GmbH 1 0 2020-11-06
Dmg Digital Enterprises SE 1 0 2021-09-03
Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. 1 0 2023-09-14
Guangzhou Heygears IMC., Inc. 1 1 2026-03-02
Meris Investment Group 1 0 2023-10-13
Bernhard Förster GmbH 1 0 2024-08-02
Shandong Huge Dental Material Corporation 1 0 2025-08-01
Vertex-Dental B.V. 1 0 2022-10-21
Grindguard, Inc. 1 0 2025-02-10
Mycone Dental Supply Co. Inc. (Dba Keystone Industries) 1 0 2021-04-09
Detax GmbH 1 0 2023-10-12
Myohealth Technologies, LLC 1 0 2024-02-02
Whip Mix Corporation 1 0 2025-03-18
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-03-02 K253798 Guangzhou Heygears IMC., Inc. UltraPrint-Dental Hard Splint UV
2025-12-05 K250743 Remvia Remvia NightGuard
2025-08-01 K251252 Shandong Huge Dental Material Corporation NOBILCAM IMPAK Disc
2025-03-18 K241729 Whip Mix Corporation Hard Splint & Thermo-Adaptive Splint
2025-02-10 K243516 Grindguard, Inc. Remi Custom Night Guard
2024-08-22 K241369 Lijia, LLC LIJIA Night Guard
2024-08-08 K231775 Pro3Dure Medical GR Resin System MSI
2024-08-02 K241311 Bernhard Förster GmbH Thermoforming Sheet Materials (Track A); Thermoforming Sheet Materials (Track B); Thermoforming Sheet Materials (Track E); Thermoforming Sheet Materials (Track Bleach)
2024-06-04 K240463 Slow Wave, Inc. Slow Wave DS8 (SWDS802)
2024-03-26 K231793 Belport Company, Inc., Gingi-Pak RODIN 3D Resin SPLINT, Hard/Flex
2024-02-16 K232087 Formlabs Ohio, Inc. Dental LT Comfort Resin
2024-02-02 K230548 Myohealth Technologies, LLC Myoaligner Appliance
2024-01-18 K230592 LuxCreo, Inc. LuxCreo Dental Night Guard Resin
2023-11-28 K222845 Frey Oral Technologies, LLC Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece
2023-10-13 K230495 Meris Investment Group Serena Sleep Night Guard
2023-10-12 K232448 Detax GmbH FREEPRINT® splintmaster
2023-09-14 K230237 Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd. Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0)
2023-04-21 K222604 Dentona AG dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S
2023-02-17 K223798 Prismatik Dentalcraft, Inc. Glidewell TuffSplint™ Appliance Resin
2022-11-10 K222061 Formlabs Ohio, Inc. Dental LT Clear V2 Resin
2022-10-21 K221022 Vertex-Dental B.V. NextDent Ortho Flex
2022-06-10 K220894 Envisiontec GmbH SmileGuard
2022-04-08 K212017 Pro3Dure Medical GmbH Thermeo System
2022-02-23 K214102 Prismatik Dentalcraft, Inc. Glidewell Appliance Resin, Hard/Soft
2021-12-22 K212767 Splintek, Inc. SleepRight Select-Comfort Dental Guard