Oral Pain Relief Gel
Benzocaine 20%
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1222088 | 1222088 | SLEEPNET CORPORATION | 1 | N | 2026-01-01 | 5 MERRILL INDUSTRIAL DRIVE Hampton NH US 03842 |
| 3006794225 | 3006794225 | Sleep Science Partners, Inc. | 1 | N | 2026-01-01 | 700 Larkspur Landing Circle Suite 245 Larkspur CA US 94939 |
| 3007075845 | 3007075845 | SLEEP GROUP SOLUTIONS | 1 | N | 2026-01-01 | 2035 Harding St Ste 200 Hollywood FL US 33020 |
| 3008061384 | 3008061384 | SLEEPSAFE BEDS, LLC | 1 | N | 2026-01-01 | 3629 Reed Creek Dr Bassett VA US 24055 |
| 3008399755 | 3008399755 | SLEE MEDICAL GMBH | 1 | N | 2026-01-01 | Am Neuberg 14 Nieder-Olm Rhineland-Palatinate DE 55268 |
| 3008797926 | 3008797926 | SLEEPING WELL, LLC | 1 | N | 2026-01-01 | 138 Steeplebush Rd. Shelburne VT US 05482 |
| 3008812550 | 3008812550 | Sleep Specialists, LLC | 1 | N | 2026-01-01 | 150 Monument Rd Ste 207 Bala Cynwyd PA US 19004 |
| 3009132214 | 3009132214 | SLEEP JOY INTERNATIONAL LLC | 1 | N | 2026-01-01 | 140 Main St Northport NY US 11768 |
| 3011461072 | 3011461072 | Slessinger Enterprises | 1 | N | 2026-01-01 | 530 E 72nd St Apt 2f New York NY US 10021 |
| 3019315271 | 3019315271 | SLEEPM GLOBAL INC | 1 | N | 2026-01-01 | 365 Cloverleaf Dr Ste A Baldwin Park CA US 91706 |
| 3022949799 | 3022949799 | SLEEPRES, INC | 1 | N | 2026-01-01 | 1508 Carl Adams Dr Ste 200 Murfreesboro TN US 37129 |
| 3030152374 | 3030152374 | Sleep Easy Office | 1 | N | 2026-01-01 | 1320 S Main St Ste 1 South Bend IN US 46601 |
| 3031288631 | 3031288631 | SLEEPCARE, LLC | 1 | N | 2026-01-01 | 11858 La Grange Ave Fl 2 Los Angeles CA US 90025 |
| 3043842075 | 3043842075 | SLEEVE STARS LLC | 1 | Y | 2026-01-01 | 23160 Fashion Dr Ste 218 Estero FL US 33928 |
| 3006097619 | 3006097619 | SLENDERTONE DISTRIBUTION INC. | 1 | Y | 2020-04-25 | 221 River Street 9th Floor Hoboken NJ US 07030 |
| 3014439254 | 3014439254 | SLEEP 8, INC | 1 | N | 2020-04-25 | 1569 Mallory Lane Bldg 200 Brentwood TN US 37027 |
| 3015544945 | 3015544945 | SLED DISTRIBUTION LLC | 1 | Y | 2020-04-25 | 120 North Redwood Rd. Ste. A North Salt Lake UT US 84054 |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 74124 | 2030258217 | K954128 | SNOREMASTER | LRK | 1995-10-02 |
| 84368 | 1563411712 | K921452 | ACOUSTIC RHINOMETER | BXQ | 1993-07-08 |
| 74296 | 1108439391 | K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | BZD | 2026-01-15 |
| 74296 | 1391796290 | K241943 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask | CBK | 2024-08-28 |
| 74296 | 1929062268 | K241830 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask | BZD | 2024-10-18 |
| 74296 | 1832729532 | K241661 | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask | BZD | 2024-07-10 |
| 74296 | 1775632669 | K241520 | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask | CBK | 2024-06-27 |
| 74296 | 1706756030 | K241469 | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | BZD | 2024-06-15 |
| 124349 | 1379105667 | K213088 | ZQuiet Advance | LRK | 2022-06-15 |
| 74296 | 1711951186 | K203601 | Innova Nasal Non-Vented Mask | BZD | 2021-04-30 |
| 74296 | 1765217025 | K190533 | Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented | CBK | 2019-07-26 |
| 74296 | 1344695128 | K190254 | Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask | BZD | 2019-07-05 |
| 74124 | 1760903496 | K190058 | PureSleep (OTC use) | LRK | 2019-04-11 |
| 328787 | 1692396017 | K183270 | Silent Nite sl | LRK | 2019-07-17 |
| 124349 | 1507500816 | K180124 | ZQuiet | LRK | 2018-06-12 |
| 84368 | 1031100941 | K170071 | SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer | BXQ | 2017-11-09 |
| 124349 | 1931009698 | K140777 | ZQUIET-SA | LRK | 2014-07-25 |
| 124349 | 1739184952 | K122475 | ZQUIET PRO-PLUS | LRK | 2012-12-07 |
| 74296 | 1827618114 | K121692 | MINIME 2 NASAL MASK | BZD | 2012-11-05 |
| 74296 | 1294397945 | K121321 | HARD SHELL VENTED NASAL MASK | BZD | 2012-11-30 |
| 74296 | 1896499723 | K120463 | MOJO, VERASEAL | BZD | 2012-07-27 |
| 74124 | 1449395211 | K113022 | PURESLEEP | LRK | 2012-06-11 |
| 74296 | 1278615474 | K102317 | IQ VENTILATION NASAL MASK | BZD | 2011-05-17 |
| 130221 | 1884277826 | K101709 | LAMBERGSLEEPWELL- SMARTRUSION (LSW-S) | LRK | 2010-08-18 |
| 124333 | 1429669994 | K100160 | ZZOMA POSITIONAL SLEEPER MODEL 001 | MYB | 2010-05-11 |
| 124349 | 1618645139 | K093407 | ZQUIET MOUTHPIECE | LRK | 2010-06-22 |
| 74296 | 1424843016 | K090935 | MINIME PEDIATRIC MASK | BZD | 2009-07-01 |
| 124349 | 1549675619 | K090503 | ZQUIET MOUTHPIECE | LRK | 2009-03-10 |
| 74296 | 1596680692 | K063806 | SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED | CBK | 2007-05-17 |
| 124349 | 1344954540 | K040491 | CHIN-UP STRIP | LWF | 2004-09-10 |
| 74296 | 1669274874 | K021534 | IQ NASAL MASK, MODEL 50160 REV. D | BZD | 2002-07-02 |
| 84368 | 1536442803 | K011329 | ECCOVISION ACOUSTIC DIAGNOSTIC IMAGING ACOUSTIC PHARYNGOMETER | BXQ | 2002-07-26 |
| 74296 | 1212714433 | ||||
| 221266 | 1418213510 | ||||
| 74296 | 1537494379 | ||||
| 74296 | 1549990128 | ||||
| 74296 | 1978206786 | ||||
| 109322 | 1041138709 | ||||
| 109322 | 1048573340 | ||||
| 211864 | 1059016386 | ||||
| 211864 | 1098644990 | ||||
| 323598 | 1111828125 | ||||
| 348676 | 1140080676 | ||||
| 211864 | 1209262206 | ||||
| 293283 | 1230657309 | ||||
| 211864 | 1233866564 | ||||
| 293283 | 1326502593 | ||||
| 328787 | 1354086056 | ||||
| 323598 | 1385653903 | ||||
| 211864 | 1437638445 | ||||
| 293283 | 1518008933 | ||||
| 180281 | 1573184443 | ||||
| 109322 | 1601814275 | ||||
| 348676 | 1667410649 | ||||
| 211864 | 1709711058 | ||||
| 323598 | 1758681947 | ||||
| 211864 | 1891657728 | ||||
| 109322 | 1899819684 | ||||
| 306128 | 1901959922 | ||||
| 211864 | 1922085012 | ||||
| 211864 | 1922899462 | ||||
| 124349 | 1946829302 | ||||
| 211864 | 2003468055 | ||||
| 124349 | 2011949052 | ||||
| 211864 | 2039217225 | ||||
| 348676 | 2066883697 |
Benzocaine 20%
Bacitracin zinc, Neomycin sulfate, Polymyxin B sulfate
White petrolatum
Arnica montana
Calendula Officinalis Flower Extract
Ethyl Alcohol
Homosalate, Titanium Dioxide, Ethylhexyl Salicylate, Phenylbenzimidazole Sulfonic Acid
Sleepnet Corporation
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SLEEPNET CORPORATION