510(k) K261134
- Device
- Dormiva Anti-Snoring Mouth Guard
- Applicant
- Koncept Innovators, Inc.
- 510(k) number
- K261134
- Product code
- LRK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-05-14
- Date received
- 2026-04-07
- Regulation
- 872.5570
- Classification name
- Device, Anti-Snoring
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Maureen Garner
- Address
- 1619 Executive Ave. Myrtle Beach SC US 29577 29577
FDA Registration Numbers
- 3005343849
- 3015989643
- 1825660
- 3009401301
- 3008583502
- 3006794225
- 3027579589
- 3015128224
- 3008313791
- 3002911411
- 3008102163
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- 2031093
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- 3007233968
- 3004935484
- 1420088
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- 3006650414
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- 3043364471
- 3013445151
- 3015674959
- 3003496134
- 3025124
- 3038209294
- 3016674860
- 1045254
- 3007616887
- 3010358861
- 3010347083
- 3012728846
- 3039443708
- 3025306497
- 3000171384
- 3017567754
- 3012716038
- 1000118628
- 3012539501
- 2518422
- 3013116677
- 3028271666
- 3008808087
- 3012359952
- 1937100
- 3004748290
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- 3013934196
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- 3004038575
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- 3015169722
- 3007108578
- 3003928050
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- 3021841051
- 1048735
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- 3030914478
- 3005730680
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- 3009549393
- 3006786034
- 8010019
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- 3008159012
- 3013156109
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- 3008763803
- 3008274496
- 3030562551
- 3010324114
- 3009549313
- 3031978086
- 3018094310
- 3022315836
Source Documents
Other 510(k) Records For Product Code LRK
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252942 | ShaeferH | Shaeferh, LLC | 2026-04-10 |
| K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | Ram.Shaw Pte. , Ltd. | 2026-03-03 |
| K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. | 2026-03-02 |
| K252976 | Park Dental Nylon MAD | Park Dental Research Corp. | 2025-12-18 |
| K253868 | QuietLab Pro | QuietLab, LLC | 2025-12-05 |
| K252161 | Hushd Avera | Good Sleep CO Pte , Ltd. | 2025-11-25 |
| K252525 | AIO Breathe | Aiomega, LLC | 2025-11-06 |
| K252698 | NightGuard Aire Max | Nightguard Express, LLC | 2025-11-03 |
| K253355 | Difiney Advanced Anti Snoring Device 4.0 | Fissiontech, LLC | 2025-10-29 |
| K251784 | Hushd Pro Z-Link | Good Sleep CO Pte , Ltd. | 2025-10-24 |
| K251628 | Mandibular Advancement Device L07 | Dcstar, Inc. | 2025-10-22 |
| K250028 | Anti Snore Mouthpiece | Dongguan Yiyao Science & Technology Development Co., Ltd. | 2025-10-03 |
| K243752 | Double Tube Herbst Appliance | The Tmj Clinic PC | 2025-09-17 |
| K252374 | Nylon flexTAP(R) | Airway Technologies D/B/A Airway Management | 2025-09-11 |
| K250353 | Oniris; Oniris Plus | Oniris | 2025-09-04 |