Chrysalis Intelligence · Product Codes · OBR

OBR · Unclassified

16 clearances · 13 unique sponsors

Device class
Regulation —
Total clearances
16
2020-01-15 → 2026-06-25
Last 12 months
5
Unique sponsors
13
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
Splintek, Inc. 2 0 2021-12-13
Boyd Research, Inc. 2 0 2021-09-17
Doc Brands, Inc. 2 0 2025-05-19
1987 Media Limited 1 1 2026-04-10
Encore Guards 1 1 2025-11-25
Dimedikorea 1 0 2024-04-17
Remi 1 1 2025-10-17
Reazeal Corp 1 0 2023-11-06
Medtech Products, Inc. 1 0 2020-12-22
Owl Dental Lab, Inc. 1 1 2026-02-26
Fbcc, Inc. 1 0 2022-11-18
Xiamen Yizhou Imp. & Exp. Co., Ltd. 1 0 2024-05-24
ASESSO HEALTH, Inc. 1 1 2026-06-25
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-06-25 K260790 ASESSO HEALTH, Inc. G-Series Grind Guard
2026-04-10 K252485 1987 Media Limited ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))
2026-02-26 K253641 Owl Dental Lab, Inc. Owl Night Guard
2025-11-25 K252004 Encore Guards enCore Night Guard
2025-10-17 K251778 Remi Remi Custom Night Guard
2025-05-19 K250456 Doc Brands, Inc. Dentemp Pro-Comfort Dental Guard
2024-05-24 K240810 Xiamen Yizhou Imp. & Exp. Co., Ltd. Anti Grinding Guard
2024-04-17 K232238 Dimedikorea Goyo Mouthpiece S
2023-11-06 K231865 Reazeal Corp Mouth Guard (ATG0603R)
2022-11-18 K221369 Fbcc, Inc. FBCC Night Guard
2022-10-07 K222424 Doc Brands, Inc. Protect-It Custom Fit Dental Guard
2021-12-13 K212706 Splintek, Inc. SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard
2021-09-17 K211158 Boyd Research, Inc. NTI ClenchGuard
2020-12-22 K202974 Medtech Products, Inc. DenTek Fresh Protect Dental Guard
2020-06-01 K193577 Splintek, Inc. SleepRight ProRx Custom Dental Guard
2020-01-15 K181005 Boyd Research, Inc. ClenchGuard