FDA.reportPublic FDA data

VeriFIT Splint

Primary DI
D040711830
Brand
VeriFIT Splint
Company
WHIP-MIX CORPORATION
Model
71183
Device description
3D printing Thermo adaptive Splint resin
Published
2025-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K241729000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241729000Hard Splint & Thermo-Adaptive SplintWhip Mix Corporation2025-03-18MQC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D040711830PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). 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
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
D040022720#2240Q ART/#8645 FACE BOW IN BOX02272-S2025-09-11
D040342160MA2340 W/STRAPS342162025-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EPRCD1001501printodent GR-19.1 OApro3dure medical GmbHMQC2023-08-29
EPRCD1001504printodent GR-19.1 OA I MSIpro3dure medical GmbHMQC2023-08-29
08719425509549Vertex-Dental BVVertex-Dental B.V.KMY2023-06-20
EPRCD1001609PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
EPRCD1001610PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
EPRCD1001611PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
EPRCD1001703PRO3DURE GR-22 flex pro3dure medical GmbHKMY2022-02-14
EPRCD1001704PRO3DURE GR-22 flex pro3dure medical GmbHKMY2022-02-14
EPRC66077916dima Print Splint clear pro3dure medical GmbHMQC2021-11-25
EPRC66077916dima Print Splint clear pro3dure medical GmbHKMY2021-11-25
EPRCD1000800PRO3DURE GR-10 guidepro3dure medical GmbHKMY2021-10-29
EPRCD1000801PRO3DURE GR-10 guidepro3dure medical GmbHKMY2021-10-29
EPRCD1001491PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001492PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001493PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001701PRO3DURE GR-22 flex pro3dure medical GmbHKMY2021-10-29
EPRCD1001702PRO3DURE GR-22 flex pro3dure medical GmbHKMY2021-10-29
ERKO5142052ErkolenErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5142072ErkolenErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5142102ErkolenErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5212051ErkodurErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5212401ErkodurErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5215081ErkodurErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5215401ErkodurErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5219061Erkodur-A1Erkodent Erich Kopp GmbHKMY2021-09-21
ERKO5222061Erkodur-A1Erkodent Erich Kopp GmbHKMY2021-09-21
ERKO5222101Erkodur-A1Erkodent Erich Kopp GmbHKMY2021-09-21
ERKO5222201Erkodur-A1Erkodent Erich Kopp GmbHKMY2021-09-21
ERKO5226061Erkodur-0M1Erkodent Erich Kopp GmbHKMY2021-09-21
ERKO5226101Erkodur-0M1Erkodent Erich Kopp GmbHKMY2021-09-21