FDA.reportPublic FDA data

KeyPrint

Primary DI
H66842200081
Brand
KeyPrint
Company
Keystone Industries
Model
4220008
Catalog number
4220008
Device description
KeyOrtho IBT 1KG
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
QJJIndirect bonding tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJJIndirect Bonding TrayDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H66842200081PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume35.3Fluid Ounce
Weight1Kilogram

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
Premarket exempt
true
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
10850061082029Custom Orthodontic SolutionKlowen Braces, Inc.QJJ2026-05-26
06956748704417Angel AlignerWuxi EA Medical Instruments Technologies Limited.QJJ2026-05-19
D9821716150LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
D9821716160LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
D9821716170LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
D9821716180LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
D9821716190LuxaPrint Ortho Flex NXDMG Digital Enterprises SEQJJ2026-05-06
00850070544832IDB 3 Sprintray, Inc.QJJ2026-03-17
00860012928408CelebraceCelebrace Inc.QJJ2025-03-28
00850061082015Custom Digital OrthodonticsKlowen Braces, Inc.QJJ2024-11-21
09359215000055DentaIBTASIGA PTY LTDQJJ2024-02-06
D865REF06001ClearCorrect System Engager TemplateClearcorrect Operating, LLCQJJ2024-02-02
07290018915028MED610STRATASYS LTDQJJ2024-01-10
07290018915219MED610STRATASYS LTDQJJ2024-01-10
07290018915417MED610STRATASYS LTDQJJ2024-01-10
07290018915615MED610STRATASYS LTDQJJ2024-01-10
07290018915813MED610STRATASYS LTDQJJ2024-01-10
D865REF02001ClearCorrect SystemClearcorrect Operating, LLCQJJ2023-08-25
00816063022169Attachment TemplateAlign Technology, Inc.QJJ2023-07-24
D82854001600Indirect BondFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCQJJ2022-12-12
D82854001610Indirect Bond W/Hard ShellFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCQJJ2022-12-12
D82854001660Indirect Bond-EZ_HardSoftFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCQJJ2022-12-12
D8285401650Digital Indirect BondFIVE STAR ORTHODONTIC LABORATORY & SUPPLY INCQJJ2022-12-12
D918DOCWT0Digital Orthodontic CareDigital Orthodontic CareQJJ2022-12-09
H66842000081KeyPrintKeystone IndustriesQJJ2022-11-30
D9821712500LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01
D9821712510LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01
D9821712520LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01
D9821712530LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01
D9821712730LuxaPrint Ortho Flex 385DMG Digital Enterprises SEQJJ2022-09-01