FDA.reportPublic FDA data

Proform

Primary DI
H66896047001
Brand
Proform
Company
Keystone Industries
Model
9604700
Catalog number
9604700
Device description
E-Gasket Clear 12 Each
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQCMouthguard, prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQCMouthguard, PrescriptionUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H66896047001PrimaryHIBCC0
H66896047000Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Special Storage Condition, Specify00Keep out of sunlight

Contacts#

Phone, Email table
PhoneEmail
+1(800)333-3131tschwear@keystoneind.com

Regulatory Flags#

DUNS number
073503117
Device count
12
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H66842201141HeyGears422011442201142023-02-20
H66842201151KeySplint Soft for HeyGears422011542201152021-07-06
H66850524011Nexa3D425020542502052023-02-20
H66852233011Nexa3D425020442502042023-02-20
H6682030051iSmile070137707013772023-02-20
H66807003771Seity070037707003772016-09-15
H66807021771M&S070217707021772017-10-11
H66807027771Seity070277707027772016-10-26
H66842204400Carbon 422044042304402025-08-28
H66842204410Carbon 422044142304412025-08-28
H66842204420Carbon 422044242304422025-08-28
H66842204401Carbon 422044042304402025-08-28
H66842204411Carbon 422044142304412025-08-28
H66842204421Carbon 422044242304422025-08-28
H668166361BOSWORTH16636166362022-11-30
H668166961BOSWORTH16696166962022-11-30
H66811475771Keystone Industries114757711475772022-11-30
H66811475781Keystone Industries114757811475782022-11-30
H668166301BOSWORTH16630166302022-11-30
H668166321BOSWORTH16632166322022-11-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
00815967026112RodinPac-Dent, Inc.MQC2026-05-20
00190730084583Sports AdvantageORTHO TECHNOLOGY, INC.MQC2025-07-24
00190730084590Sports AdvantageORTHO TECHNOLOGY, INC.MQC2025-07-24
H66842000141KeyPrintKeystone IndustriesMQC2024-09-26
H66841101411KeyPrintKeystone IndustriesMQC2023-09-25
H66842201511KeyPrintKeystone IndustriesMQC2023-09-25