FDA.reportPublic FDA data

OptiGuard

Primary DI
00195062164422
Brand
OptiGuard
Company
Kerr Corporation
Model
25880
Device description
Light Cure Sealant Refill 5ml
Published
2026-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195062164422PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195062164422001950621644221950621644220195062164422

GMDN Terms#

Term, Definition table
TermDefinition
Dental unfilled resin sealant/coatingA non-sterile, resin-based dental material intended for professional use as a sealant, coating, and/or glazing material during dental restoration (e.g., pit/fissure sealing and/or restorative composite resin sealing/coating), whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled resin; it does not include any significant inorganic filler materials and is therefore not classed as a composite resin. It may be preloaded into an applicator. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
800-537-7123kerrcustcare@kavokerr.com

Regulatory Flags#

DUNS number
199354556
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
00195062160110NX3336422026-10-29
00195062164439OptiGuard266852026-10-29
10841396117883Optidisc334752026-10-29
00195062159787BreezeN97E2026-10-27
00195062159794Breeze RMGIN982026-10-27
00195062160332Build-It FRN32AA2026-10-27
00195062160349Build-It FRN32AB2026-10-27
00195062160356Build-It FRN32AC2026-10-27
00195062160363Build-It FRN32AD2026-10-27
00195062160370Build-It FRN32AE2026-10-27
00195062160387Build-It FRN32FS2026-10-27
00195062160394Build-It FRN32FSA2026-10-27
00195062160400Build-It FRN32FSB2026-10-27
00195062160417Build-It FRN32FSC2026-10-27
00195062160424Build-It FRN32FSD2026-10-27
00195062160431Build-It FRN32FA2026-10-27
00195062160448Build-It FRN32FB2026-10-27
00195062160455Build-It FRN32FC2026-10-27
00195062160462Build-It FRN32FD2026-10-27
00195062160479Build-It FRN32FE2026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195062164439OptiGuardKerr CorporationEBF2026-10-29
00195062160332Build-It FRKerr CorporationEBF2026-10-27
00195062160349Build-It FRKerr CorporationEBF2026-10-27
00195062160356Build-It FRKerr CorporationEBF2026-10-27
00195062160363Build-It FRKerr CorporationEBF2026-10-27
00195062160370Build-It FRKerr CorporationEBF2026-10-27
00195062160387Build-It FRKerr CorporationEBF2026-10-27
00195062160394Build-It FRKerr CorporationEBF2026-10-27
00195062160400Build-It FRKerr CorporationEBF2026-10-27
00195062160417Build-It FRKerr CorporationEBF2026-10-27
00195062160424Build-It FRKerr CorporationEBF2026-10-27
00195062160431Build-It FRKerr CorporationEBF2026-10-27
00195062160448Build-It FRKerr CorporationEBF2026-10-27
00195062160455Build-It FRKerr CorporationEBF2026-10-27
00195062160462Build-It FRKerr CorporationEBF2026-10-27
00195062160479Build-It FRKerr CorporationEBF2026-10-27
00195062160486Build-It FRKerr CorporationEBF2026-10-27
00195062160493Build-It FRKerr CorporationEBF2026-10-27
06970006745677Universal Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746575TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746582TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746599TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746605TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746612TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746629TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746636TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746643TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746650TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746667TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25
06970006746674TrusFIL-Flow Flowable Composite RestorativeRizhao HuGe Biomaterials Company, Ltd.EBF2026-10-25