FDA.reportPublic FDA data

KeyPrint

Primary DI
H66842000051
Brand
KeyPrint
Company
Keystone Industries
Model
4200005
Catalog number
4200005
Device description
KeySplint Soft 0.5 kg sample
Published
2019-12-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KMYPOSITIONER, TOOTH, PREFORMED
MQCMouthguard, prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1
MQCMouthguard, PrescriptionUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183598000KeyPrint KeySplint SoftKeystone Industries2019-11-15MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H66842000052PackageHIBCC8In Commercial Distribution
H66842000051PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, curedA resin that polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured) intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture base, occlusal splint/night guard); it may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). It consists of a reactive component (e.g., acrylic monomer, reactive polymer) that hardens via polymerization [or vulcanization]. Reinforcing fillers may be included in the resin to increase its strength and/or durability. After application, this material cannot be refabricated.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume17.6Fluid Ounce
Weight0.5Gram
Weight0.5Kilogram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from moisture
Special Storage Condition, Specify00Keep out of direct sunlight
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
073503117
Device count
1
Lot or batch
true
Expiration 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
08054154160013EQUILIBRATORE 1.0EPTAMED SRLKMY2026-07-28
08054154160020EQUILIBRATORE 1.05EPTAMED SRLKMY2026-07-28
08054154160037EQUILIBRATORE 1.1EPTAMED SRLKMY2026-07-28
08054154160051EQUILIBRATORE 1.2 YOUNGEPTAMED SRLKMY2026-07-28
08054154160143EQUILIBRATORE 3.2EPTAMED SRLKMY2026-07-28
08054154160150EQULIBRATORE 3.3EPTAMED SRLKMY2026-07-28
08054154160198EquiIlibratore C2EPTAMED SRLKMY2026-07-28
08054154160204Equilibratore C3EPTAMED SRLKMY2026-07-28
08054154160211Equilibratore C4EPTAMED SRLKMY2026-07-28
08054154160228EQUILIBRATORE C3PEPTAMED SRLKMY2026-07-28
08054154160259EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160266EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160273EQUILIBRATORE E-FITEPTAMED SRLKMY2026-07-28
08054154160297FREEDOMEPTAMED SRLKMY2026-07-28
08054154160303EQUILIBRATORE GENIUS 3EPTAMED SRLKMY2026-07-28
08054154160334EQUILIBRATORE NIKI 1EPTAMED SRLKMY2026-07-28
08054154160372EQUILIBRATORE 003EPTAMED SRLKMY2026-07-28
08054154160402EQUILIBRATORE SL3 YOUNGEPTAMED SRLKMY2026-07-28
08054154160426EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154160433EQUILIBRATORE U4EPTAMED SRLKMY2026-07-28
08054154160501EQULIBRATORE U2EPTAMED SRLKMY2026-07-28
08054154160563EQUILIBRATORE GENIUSEPTAMED SRLKMY2026-07-28
08054154160761EQUILIBRATORE NIKI 2EPTAMED SRLKMY2026-07-28
08054154160815EQUILIBRATORE GENIUSEPTAMED SRLKMY2026-07-28
08054154160822EQUILIBRATORE GENIUS 2EPTAMED SRLKMY2026-07-28
08054154160945EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154160969EQUILIBRATORE U3EPTAMED SRLKMY2026-07-28
08054154161089EQULIBRATORE 1.1EPTAMED SRLKMY2026-07-28
08054154161126EQUILIBRATORE C3P YOUNGEPTAMED SRLKMY2026-07-28
08054154161164EQULIBRATORE U4 YOUNGEPTAMED SRLKMY2026-07-28