FDA.reportPublic FDA data

Slow Wave

Primary DI
00860007686627
Brand
Slow Wave
Company
Slow Wave, Inc.
Model
BROSA
Published
2025-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LRKDevice, Anti-Snoring
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LRKDevice, Anti-SnoringDental2
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240463000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240463000Slow Wave DS8 (SWDS802)Slow Wave, Inc.2024-06-04MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007686627PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007686627008600076866278600076866270860007686627

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made mouthguardA custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
035177408
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860007686603Slow WaveDS8SWDS8012023-05-03
00860007686610Slow WaveATSWAT012023-05-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00821514000054Good Morning Snore SolutionMPowRx Health and Wellness Products 2012 IncLRK2026-07-16
04260670160510dentona flexisplintdentona AGMQC2026-06-23
04260670160527dentona flexisplintdentona AGMQC2026-06-23
04260670160534dentona flexisplintdentona AGMQC2026-06-23
04260670160541dentona flexisplintdentona AGMQC2026-06-23
04260670160558dentona flexisplintdentona AGMQC2026-06-23
04260670160572dentona flexisplintdentona AGMQC2026-06-23
04260670160589dentona flexisplintdentona AGMQC2026-06-23
04260670160596dentona vivatempdentona AGMQC2026-06-23
04260670160602dentona vivatempdentona AGMQC2026-06-23
04260670160619dentona vivatempdentona AGMQC2026-06-23
04260670160626dentona vivatempdentona AGMQC2026-06-23
04260670160633dentona vivatempdentona AGMQC2026-06-23
04260670160640dentona vivatempdentona AGMQC2026-06-23
04260670160657dentona vivatempdentona AGMQC2026-06-23
04260670160688optimill memosplintdentona AGMQC2026-06-23
04260670160695optimill memosplintdentona AGMQC2026-06-23
04260670160701optimill memosplintdentona AGMQC2026-06-23
04260670160718optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160725optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160732optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160749optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160756optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160664optimill memosplintdentona AGMQC2026-06-22
04260670160671optimill memosplintdentona AGMQC2026-06-22
D854413871967328267319ApnoDentSELANE PRODUCTS, INC.LRK2026-05-29
00815967026112RodinPac-Dent, Inc.MQC2026-05-20
00190730084583Sports AdvantageORTHO TECHNOLOGY, INC.MQC2025-07-24
00190730084590Sports AdvantageORTHO TECHNOLOGY, INC.MQC2025-07-24
H66842000141KeyPrintKeystone IndustriesMQC2024-09-26