FDA.reportPublic FDA data

SOVA

Primary DI
00858286007646
Brand
SOVA
Company
Akervall Technologies, Inc.
Model
Aero
Device description
SOVA Aero 1.6mm Ecommerce Packaging
Published
2023-02-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
OBRMouthguard, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBRMouthguard, Over-The-CounterUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121272000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121272000PROTECH DENTAkervall Technologies, Inc.2012-10-15OBR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858286007646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858286007646008582860076468582860076460858286007646

GMDN Terms#

Term, Definition table
TermDefinition
Dental occlusal splint, customizableA device intended for home-use intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). The device is typically made of plastic materials and can be softened, typically in hot water, and moulded over the teeth by the user to provide an anatomical fit (customizable). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth1.6Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
023254296
Device count
1
Lot or batch
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00860015217721enCore Night GuardENCORE LABORATORY LLCOBR2026-03-02
00860015217738enCore Night GuardENCORE LABORATORY LLCOBR2026-03-02
00860015217707enCore Night GuardENCORE LABORATORY LLCOBR2026-01-08
00692121032055SleepRightSplintek Inc.OBR2025-12-17
00692121032062SleepRightSplintek Inc.OBR2025-12-17
00692121032246SleepRightSplintek Inc.OBR2025-12-17
00692121035438SleepRightSplintek Inc.OBR2025-12-17
00860013500702Custom Night GuardGrindGuard Inc.OBR2025-03-17
00087701190667Good Neighbor PharmacyAmerisourcebergen Drug CorporationOBR2025-03-03
20087701190661Good Neighbor PharmacyAmerisourcebergen Drug CorporationOBR2025-03-03
00195515045247Amazon BasicsAMAZON.COM SERVICES LLCOBR2025-01-25
10195515045244Amazon BasicsAMAZON.COM SERVICES LLCOBR2025-01-25
00651080651523PlackersRANIR, LLCOBR2024-04-26
10651080651520PlackersRANIR, LLCOBR2024-04-26
00713733567404MeijerMEIJER, INC.OBR2024-04-17
00050428270691CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDOBR2024-04-16
10050428270698CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDOBR2024-04-16
00311917046877WalgreensWALGREEN CO.OBR2024-01-18
10311917046874WalgreensWALGREEN CO.OBR2024-01-18
00692121035216SleepRightSplintek Inc.OBR2023-08-30
00866618000036GrindRelief PROGrind Guard Technologies, L.L.C.OBR2023-07-18
00866618000043GrindRelief PROGrind Guard Technologies, L.L.C.OBR2023-07-18
00866618000050GrindRelief PROGrind Guard Technologies, L.L.C.OBR2023-07-18
10866618000033GrindRelief PROGrind Guard Technologies, L.L.C.OBR2023-07-18
00033732010306LunaGuardMcKeon Products, Inc.OBR2022-10-07