Device, Jaw Repositioning
Dental · 21 CFR 872.5570
Recent MDR events
19 adverse event reports on file
- MMRNANov 23, 2021InjuryVivos Therapeutics Inc.MW5105562
- MH-601 JAWS UNIT FOR T1101Feb 14, 2021MalfunctionOlympus Medical Systems Corp.8010047-2021-02611
- NARVAL CCAug 7, 2017InjuryResmedMW5071451
- NARVALJul 12, 2016InjuryResmedMW5063436
- NARVAL CC ORTHESE MRDJun 2, 2016InjuryResmed Sas3004604967-2016-00580
- NTI TENSION SUPPRESSION SYSTEMFeb 11, 2016InjuryTherapeutic Solutions InternationalMW5060226
- NTI TENSION SUPPRESSION SYSTEMFeb 11, 2016InjuryTherapeutic Solutions InternationalMW5060227
- NARVAL CC ORTHESE MRDJul 30, 2014InjuryResmed Sas3004604967-2014-00018
- NARVAL CC ORTHESE MRDJul 30, 2014InjuryResmed Sas3007573469-2014-00007
- NARVAL CC ORTHESE MRDOct 31, 2012OtherResmed Sas - Dental Sleep Business3004604967-2012-00042
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
47 firms currently registered for this product code
Crane Dental Laboratory
Rochester, NY, US
Slow Wave, Inc.
Lakeway, TX, US
Johns Dental Laboratory
Terre Haute, IN, US
Apex Dental Sleep Lab
La Mesa, CA, US
Oral Arts Laboratory, Inc.
Huntsville, AL, US
Xiamen Yizhou Imp. & Exp. Co., Ltd.
Xiamen Fujian, CN
Sleep Joy International Llc
Northport, NY, US
Vivos Therapeutics Inc.
Murray, KY, US
Digital Dental Depot Limited
Hong Kong, HK
Fissiontech Llc
New York, NY, US
Aurum Ceramic Dental Laboratories Ltd.
CALGARY Alberta, CA
Modern Dental Laboratory (dg) Co., Ltd.
Dongguan Guangdong, CN
Davis Dental Lab
Wyoming, MI, US
Koncept Innovators, Llc
Myrtle Beach, SC, US
Shun Hsiang Plastic Co.,ltd.
Taoyuan, TW
Ema-sleep Inc
Bastrop, TX, US
Apnomed, Inc.
Bellevue, WA, US
Island Dental Lab Dba Emerald Dental Lab
Valley Stream, NY, US
Space Maintainers Lab
CHATSWORTH, CA, US
Aiomega, Llc
Tyler, TX, US
510(k) clearances
27 clearances for this product code
- Aiomega, LLCFeb 23, 2024
K233754 · AIO Breathe
- Achaemenid, LLCJul 12, 2023
K230532 · RADx Intraoral Appliance for Snoring and Sleep Apnea
- Biotex, Inc.Jul 20, 2021
K203712 · The Slide
- Slow Wave, Inc.Oct 2, 2020
K191320 · Slow Wave DS8
- Advanced Facialdontics, LLCJan 28, 2020
K192581 · The NightBlocks Appliance
- Selane Products, Inc.Jul 27, 2017
K162816 · SML-OSA2 Appliances
- Selane Products, Inc.Aug 26, 2013
K130130 · ATG/SM-OSA APPLIANCES
- Millenium Dental Laboratory, Inc.Jun 6, 2012
K112627 · MILLENIUM ANTI-SNORING DEVICE