FDA.reportPublic FDA data

Keystone Keysplint Soft 1Kg

Primary DI
D040711861
Brand
Keystone Keysplint Soft 1Kg
Company
WHIP-MIX CORPORATION
Model
71186
Device description
Keystone Keysplint Soft 1 Kg
Published
2021-08-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D040711861PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
006385173
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D04071079C1Surgical Guide for Carbon71079-C2021-06-07
D040711751Veriguide OS71175711752020-09-22
D040600001ARDENT600002025-11-05
D040600011ARDENT600012025-11-05
D040600071ARDENT600072025-11-05
D040600081ARDENT 600082023-10-27
D040602061ARDENT 602062023-10-27
D040600021ARDENT DISPOSABLE DENT600022023-08-18
D040600031ARDENT DISPOSABLE DENT600032023-08-18
D040603000Forceps- Paper603002023-08-18
D0406010072Articulating paper/film60100601002020-08-24
D0406010160Articulating paper/film60101601012020-08-24
D0406020075Articulating paper/film60200602002020-08-24
D0406020175Articulating paper/film60201602012020-08-24
D0406020275Articulating paper/film60202602022020-08-24
D04060002140Articulating paper/film60002600022020-08-17
D04060003140Articulating paper/film60003600032020-08-17
D04060004140Articulating paper/film60004600042020-08-17
D04060005144Articulating paper/film60005600052020-08-17
D04060006144Articulating paper/film60006600062020-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06909412314672Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314689Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314696Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314702Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314719Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314726Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314733Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314740Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314757Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314764Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314771Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314788Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314795Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314801Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
06909412314818Milling DiscSHANDONG HUGE DENTAL MATERIAL CORPORATIONMQC2026-10-25
00860012026135DaybreakSleepcare LLCKMY2026-10-19
08054154160044EQUILIBRATORE 1.2EPTAMED SRLKMY2026-08-27
08054154160068EQULIBRATORE 1.3EPTAMED SRLKMY2026-08-27
08054154160082EQUILIBRATORE 1.4EPTAMED SRLKMY2026-08-27
08054154160242EQUILIBRATORE C4PEPTAMED SRLKMY2026-08-27
08054154161041EQUILIBRATORE 1.0EPTAMED SRLKMY2026-08-27
08054154161058EQUILIBRATORE 1.0EPTAMED SRLKMY2026-08-27
08054154161065EQUILIBRATORE 1.05EPTAMED SRLKMY2026-08-27
08054154161072EQUILIBRATORE 1.05EPTAMED SRLKMY2026-08-27
08054154161096EQUILIBRATORE 1.1EPTAMED SRLKMY2026-08-27
08054154161102EQUILIBRATORE 1.1EPTAMED SRLKMY2026-08-27
08054154161218EQUILIBRATORE 1.2EPTAMED SRLKMY2026-08-27
08054154161225EQUILIBRATORE 1.2EPTAMED SRLKMY2026-08-27
08054154161232EQUILIBRATORE 1.2EPTAMED SRLKMY2026-08-27
08054154161249EQUILIBRATORE 1.2-SEPTAMED SRLKMY2026-08-27