FDA.reportPublic FDA data

Bio-LCB

Primary DI
00766054002918
Brand
Bio-LCB
Company
ESSENTIAL DENTAL SYSTEMS, INC.
Model
910-03
Catalog number
910-03
Device description
Light Cured Base and Liner Syrinageable
Published
2022-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EJKLINER, CAVITY, CALCIUM HYDROXIDE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJKLiner, Cavity, Calcium HydroxideDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K134022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K134022000BASE ITSpident Co., Ltd.2014-06-11EJK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00766054002918PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00766054002918007660540029187660540029180766054002918

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
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature39 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(201)487-9090udi@edsdental.com

Regulatory Flags#

DUNS number
101147171
Device count
1
DM exempt
true
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
00766054002987Turbo-CR1100-301100-302025-04-04
00766054002994Turbo-CR1100-001100-002025-04-04
00766054003007Turbo-CR1100-1001100-1002025-04-04
00766054002949BIOSEAL1640-001640-002024-10-31
00766054002970BIOSEAL1640-151640-152024-10-31
00766054000341EDS Self Etch Bonding Agent900-00900-002017-02-01
00766054000693Tango-Endo5300-005300-002020-07-17
00766054001201Endo-Express5510-005510-002020-07-10
00766054001218Endo-Express5520-005520-002020-07-10
00766054002710Endo CSV5100-005100-002020-07-17
00766054002727Endo CSV5121-005121-002020-07-17
00766054002734Endo CSV5125-005125-002020-07-17
00766054002840Endo CSV5100-RH5100-RH2020-07-17
00766054000259EZ-Fill Bi-Directional Spiral1600-211600-212020-07-10
00766054000266EZ-Fill Bi-Directional Spiral1600-251600-252020-07-10
00766054000273EZ-Fill Bi-Directional Spiral1600-011600-012020-07-10
00766054000280EZ-Fill Bi-Directional Spiral1605-211605-212020-07-10
00766054000297EZ-Fill Bi-Directional Spiral1605-251605-252020-07-10
00766054000303EZ-Fill Bi-Directional Spiral1605-011605-012020-07-10
00766054001188Endo-Express5500-005500-002020-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850440008582ActaCal Calcium Hydroxide PasteEngineered Endodontics, LLCEJK2026-01-02
00197998302732Solventum™ Vitrebond™Solventum US LLCEJK2025-09-29
D161250010AxioPro ARTAxiodent Inc.EJK2024-10-04
D161250020AxioPro ARTAxiodent Inc.EJK2024-10-04
D161250040AxioCAL LCAxiodent Inc.EJK2024-10-04
D161250050AxioCAL LCAxiodent Inc.EJK2024-10-04
D161250060AxioCAL LCAxiodent Inc.EJK2024-10-04
D161250080AxioCAL Axiodent Inc.EJK2024-10-04
D161250090AxioCAL Axiodent Inc.EJK2024-10-04
D161250100AxioCAL Axiodent Inc.EJK2024-10-04
D161250110AxioCAL Axiodent Inc.EJK2024-10-04
D161250150AxioCAL SC Axiodent Inc.EJK2024-10-04
D161250160AxioCAL SC Axiodent Inc.EJK2024-10-04
D161250170AxioCAL LC Axiodent Inc.EJK2024-10-04
D161250180AxioPro ARTAxiodent Inc.EJK2024-10-04
00810111542937TheraCal PTBISCO INC.EJK2024-04-03
00810111542944TheraCal PTBISCO INC.EJK2024-04-03
00810118103995NuSmile NeoLINER LC Sample Pack (1 g Syringe + 5 Tips, No IFU)NUSMILE, LTD.EJK2023-11-30
08800071200017CleaniCalMARUCHIEJK2023-05-16
106058610830553M™3M COMPANYEJK2023-04-28
D95600APEXH0ApexPaste HardD.S.I DENTAL SOLUTIONS LTDEJK2023-02-15
D956APEXBIO0ApexPaste BioD.S.I DENTAL SOLUTIONS LTDEJK2023-02-15
D956APEXC2G0ApexPaste D.S.I DENTAL SOLUTIONS LTDEJK2023-02-15
D956CALPSLC0CalPaste LCD.S.I DENTAL SOLUTIONS LTDEJK2023-02-15
D9673000110ApaCal ARTPREVEST DENPRO LIMITEDEJK2023-01-03
D9673000510Cal LCPREVEST DENPRO LIMITEDEJK2023-01-03
D967400070CalcigelPREVEST DENPRO LIMITEDEJK2023-01-03
D9674000710CalcigelPREVEST DENPRO LIMITEDEJK2023-01-03
D9674000720CalcigelPREVEST DENPRO LIMITEDEJK2023-01-03
D967400080CalcigelPREVEST DENPRO LIMITEDEJK2023-01-03