FDA.reportPublic FDA data

Choice 2 Try-In Paste

Primary DI
D757C412B10
Brand
Choice 2 Try-In Paste
Company
BISCO INC.
Model
C-412B1
Catalog number
C-412B1
Device description
Choice 2 Try-In Paste B1 2g Syringe
Published
2017-06-12
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMATERIAL, TOOTH SHADE, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993192000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993192000ILLUSIONBisco, Inc.1999-10-27EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D757C412B10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental cement trialA non-sterile substance intended to be used as a guide for selecting a good aesthetic match to the final dental cement to be used in a dental restoration of appliance procedure. It is typically supplied as a water-soluble paste consisting of glycerin, mineral fillers and pigments that does not cure and is intended to be washed off from the restoration and preparation surface prior to final cementation. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(847)534-6000sales@bisco.com

Regulatory Flags#

DUNS number
053529939
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810111540995Uni-Etch w/BACE-5662E-56622022-10-10
00810111541084Etch-37E-5623EE-5623E2023-01-16
00810111541138Select HV Etch w/BACE-5916E-59162022-10-11
00810111541183Select HV EtchE-5906E-59062022-10-10
D757E5632EBM1UNI-ETCH 32% w/BAC 5gm/TipsE-5632EBME-5632EBM2017-06-12
D757E5638E1ETCH-37 37% 30gm BtlE-5638EE-5638E2017-06-12
D757E56610K1Uni-Etch 32% 30ml KitE-56610KE-56610K2017-06-12
D757E56611P1Uni-Etch 32% 30ml Refill PkgE-56611PE-56611P2017-06-12
D757E56620K1Uni-Etch 32% w/BAC 30ml KitE-56620KE-56620K2017-06-12
D757E56730K1Etch-37 30ml KitE-56730KE-56730K2017-06-12
D757E56731P1Etch-37 30ml Refill PkgE-56731PE-56731P2017-06-12
D757E56740K1Etch-37 w/BAC 30ml KitE-56740KE-56740K2017-06-12
D757E570104% Porcelain Gel Etchant 7gmE-5701E-57012017-06-12
D757E570604% Porcelain Etchant 2mlE-5706E-57062017-06-12
D757E5912PS1Select HV Etch w/BAC 1g Sample Syringe PkgE-5912PSE-5912PS2017-06-12
00810111541190Select HV EtchE-59100KE-59100K2022-11-17
00810111541220Porcelain EtchantE-5701EE-5701E2022-11-17
00810111540988Uni-Etch w/BACE-5637EBE-5637EB2022-10-11
00810111541008Uni-EtchE-5622EE-5622E2022-10-11
00810111541060Etch-37 w/BACE-5638EBE-5638EB2022-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810222900046Midas Restore - C2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00810222900053Midas Restore - C2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSprintray, Inc.EBF2026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSprintray, Inc.EBF2026-07-31
07615208476804Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476811Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476828Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476835Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208476842Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477658Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477665Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477672Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477689Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477696Tetric plus FillIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477702Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477719Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477726Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477733Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477740Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29
07615208477757Tetric plus FlowIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2026-07-29