FDA.reportPublic FDA data

Ca-Lok - Calcium Base / Liner

Primary DI
D8370575000
Brand
Ca-Lok - Calcium Base / Liner
Company
Taub Products
Model
0.9 gm Syr Evaluator
Catalog number
05-7500
Device description
Ca-Lok™ is a light-cured, calcium-filled resin with adhesive properties to dentin and seamless compatibility to other restorative materials. Ca-Lok™ is radiopaque and releases fluoride.Ca-Lok™ is used as a protective liner with adhesion, which can be placed under restorative materials and cements for many types of cavity preparations. With its flowable viscosity and unique handling characteristics, precise placement and control is achieved.
Published
2016-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
K153191000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K153191000Calcium BridgeDenali Corporation2016-02-26EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8370575000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight0.9Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat. Store at room temperature. See SDS.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1.201.798.5353customerservice@taubdental.com

Regulatory Flags#

DUNS number
067488114
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8371320370Bright SpotIV - Dark Blue - 2 oz Btl13-20372026-07-23
D8371320400Bright SpotV - Lt. Green -15 mL13-20402026-07-23
D8371320500Bright SpotVI - Pink -15 mL13-20502026-07-23
D8371320520Bright SpotVI - Pink - 2 oz13-20522026-07-23
D8371340000Bright SpotThinner - 1 oz13-40002026-07-23
D8371340010Bright SpotThinner - 2 oz13-40012026-07-23
D8371320100Bright SpotII - Red -15 mL13-20102026-07-16
D8371320200Bright SpotIII - White - No Bond -15 mL13-20202026-07-16
D8371320300Bright SpotIV - Blue -15 mL13-20302026-07-16
D8371320350Bright SpotIV - Dark Blue -15 mL13-20352026-07-16
D8370650100FUSION-Zr - Veneer CementKit - 2 Crystal Clear - 1.2ml Syringe06-50102016-12-05
D8370650200FUSION-Zr - Veneer CementKit - 2 Opal White - 1.2ml Syringe06-50202016-12-05
D8370651050FUSION-Zr - Veneer CementCrystal Clear - 3ml Syringe06-51052016-12-05
D8370651150FUSION-Zr - Veneer CementOpal White - 3ml Syringe06-51152016-12-05
D8370655000FUSION-Zr - Veneer CementCrystal Clear - 0.6mL - Sample06-55002016-12-05
D8370655100FUSION-Zr - Veneer CementOpal White - 0.6mL - Sample06-55102016-12-05
D8370655200FUSION-Zr - Veneer CementNew White - 0.6mL - Sample06-55202016-12-05
D8374610000ZERO-G Bio Implant CementKit - 7 gm Syringe - 2pk46-10002016-12-05
D8374610050ZERO-G Bio Implant Cement7 gm Syringe - 1pc46-10052016-12-05
D8374650000ZERO-G Bio Implant Cement3.5 gm Syringe - Evaluator46-50002016-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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