FDA.reportPublic FDA data

CST

Primary DI
00667147000029
Brand
CST
Company
Synca Marketing Inc
Model
CST14
Device description
FIBER FORCE CST FLOW PINK RESIN (3ML)
Published
2021-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102207000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102207000FIBER FORCESynca Marketing, Inc.2010-11-23EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00667147000029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00667147000029006671470000296671470000290667147000029

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis restorative material, unfilled resinA material designed to repair dental prostheses that consists of an unfilled polymeric resin. The material works as a bonding agent to provide a strong and long-lasting attachment to the segments of a broken or cracked prosthesis; it typically consists of a single or two-component polymeric (e.g., acrylic) resin that usually becomes a solid polymer when treated with light and/or heat. The material is used in a dentist?s office or dental laboratory to repair fixed dental prostheses and/or partial or total dentures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume3Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00avoid light
Storage Environment Temperature12 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-667-9622XX@XX.XX

Regulatory Flags#

DUNS number
247111768
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00667147001552CadiV8CADI2021-07-15
10667147000095FIBER FORCEFF080022021-07-26
10667147000101FIBER FORCEFF080042021-07-26
10667147000118FIBER FORCEFF080112021-07-26
10667147000125FIBER FORCEFF080142021-07-26
10667147000187FAST SPLINT MATRIXFSM082021-07-26
10667147000194FAST SPLINT MATRIXFSM122021-07-26
10667147000200FAST SPLINT MATRIXFSM142021-07-26
10667147000224FAST SPLINT MATRIXFSM182021-07-26
10667147000255BIOLIGHTBDT052021-07-15
10667147000262BIOLIGHTBDT112021-07-26
10667147000279BIOLIGHTBDT122021-07-26
10667147000286BIOLIGHTBDT132021-07-26
10667147000347BIOLIGHTBST1002021-07-26
10667147000354BIOLIGHTBST1202021-07-26
10667147000361BIOLIGHTBST1352021-07-26
10667147000378BIOLIGHTBST1502021-07-26
10667147000460BIOLIGHT DRILL FREEBDF062023-02-13
10667147000477BIOLIGHT DRILL FREEBDF092023-02-13
10667147000484BIOLIGHT DRILL FREEBDF122023-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942480719550FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480719567FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480720396FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480720402FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480720617FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480720624FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480721454FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480721461FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722284FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722291FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722505FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722512FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480723335FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480723342FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
00810222900206SprintRay Crown HT A1 Single-Unit Capsule - JapanSprintray, Inc.EBI2026-10-09
00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900299SprintRay Crown HT Unpigmented Single-unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900305SprintRay Crown HT A1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900312SprintRay Crown HT A2 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
08056640078321major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078338major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078345major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30
08056640078352major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-09-30