510(k) K223624
- Device
- Emerald Herbst
- Applicant
- Island Dental Lab, Inc Dba Emerald Dental
- 510(k) number
- K223624
- Product code
- LRK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-05-10
- Date received
- 2022-12-05
- Regulation
- 872.5570
- Classification name
- Device, Anti-Snoring
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Israel Wettenstein
- Address
- 76 S. Central Ave. #1d Valley Stream NY US 11580 11580
FDA Registration Numbers
- 3005343849
- 3015989643
- 1825660
- 3009401301
- 3008583502
- 3006794225
- 3027579589
- 3015128224
- 3008313791
- 3002911411
- 3008102163
- 3009495876
- 3005726841
- 3003460151
- 3002916277
- 3006098230
- 2031093
- 3018783526
- 3007233968
- 3004935484
- 1420088
- 3018783197
- 3006650414
- 3011649314
- 3005598536
- 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
- 3009779268
- 3017520337
- 3013652641
- 3013934196
- 3010022489
- 3008797926
- 3004038575
- 3013950969
- 3014680794
- 3015169722
- 3007108578
- 3003928050
- 3004964738
- 3027346720
- 3000126629
- 3009132214
- 3006038700
- 3008186372
- 3031288631
- 1316408
- 3031282374
- 3023272766
- 3002912391
- 3001295407
- 3004860162
- 3013548547
- 3039643908
- 3002706372
- 3017927175
Source Documents
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| DS1071567 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DRC052401 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DRC052403 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DRC059193 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DRC059194 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DRC060821 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DRC072960 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS1000291 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS1016666 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS1016667 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS1016668 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS1016669 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS1019898 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS1045582 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS1051027 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS1071499 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DR3064993 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS1071574 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS1071759 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS2005442 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS2005443 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS2025739 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS2025740 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS2050029 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS2055393 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS2077620 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS2077621 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS2083682 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS2083685 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
| DS2083918 | Emerald Herbst | Island Dental Lab Inc. DBA Emerald Dental Lab | 2025-04-01 |
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|---|---|---|---|
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| K252976 | Park Dental Nylon MAD | Park Dental Research Corp. | 2025-12-18 |
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| 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 |