FDA.reportPublic FDA data

primostick

Primary DI
D831PS202US0
Brand
primostick
Company
PRIMOTEC LLC
Model
PS202US
Published
2021-11-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MQCMouthguard, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030832000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030832000PRIMOSPLINT SYSTEMCosmedent, Inc.2003-09-17MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D831PS202US0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental occlusal splint, custom-madeA rigid or flexible custom-made appliance that overlays the occlusal surfaces of the teeth. It is used 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). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
153454736
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D831PS100US1PrimosplintPS100US2021-11-09
D831PS204US0primoglazePS204US2021-11-09
D831PSKIT1primosplint systemPSKIT12021-11-09
D831PMCLEAR95X200PREMIOtempPM-Clear-95x202018-09-10
D831PMCLEAR95X250PREMIOtempPM-Clear-95x252018-09-10
D831PMCLEAR98X100PREMIOtempPM-Clear-98x102018-09-10
D831PMCLEAR98X120PREMIOtempPM-Clear-98x122018-09-10
D831PMCLEAR98X140PREMIOtempPM-Clear-98x142018-09-10
D831PMCLEAR98X160PREMIOtempPM-Clear-98x162018-09-10
D831PMCLEAR98X180PREMIOtempPM-Clear-98x182018-09-10
D831PMCLEAR98X200PREMIOtempPM-Clear-98x202018-09-10
D831PMCLEAR98X250PREMIOtempPM-Clear-98x252018-09-10
D831PMMONOA195X200PREMIOtempPM-Mono-A1-95x202018-08-15
D831PMMONOA195X250PREMIOtempPM-Mono-A1-95x252018-08-15
D831PMMONOA198X160PREMIOtempPM-Mono-A1-98x162018-08-15
D831PMMONOA198X180PREMIOtempPM-Mono-A1-98x182018-08-15
D831PMMONOA198X200PREMIOtempPM-Mono-A1-98x202018-08-15
D831PMMONOA198X250PREMIOtempPM-Mono-A1-98x252018-08-15
D831PMMONOA198X300PREMIOtempPM-Mono-A1-98x302018-08-15
D831PMMONOA295X200PREMIOtempPM-Mono-A2-95x202018-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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04260670160718optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160725optimill memosplint Version Sdentona AGMQC2026-06-23
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04260670160749optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160756optimill memosplint Version Sdentona AGMQC2026-06-23
04260670160664optimill memosplintdentona AGMQC2026-06-22
04260670160671optimill memosplintdentona AGMQC2026-06-22
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