FDA.reportPublic FDA data

SHOFU RESIN GLAZE

Primary DI
E235Y00040
Brand
SHOFU RESIN GLAZE
Company
SHOFU DENTAL CORPORATION
Model
Y0004
Catalog number
Y0004
Device description
RESIN GLAZE LIQUID 6ml
Published
2021-02-03
Public version status
Update
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
EBDCoating, Filling Material, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBDCoating, Filling Material, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163568000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163568000SHOFU RESIN GLAZEShofu Dental Corporation2017-08-16EBD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
E235Y00040PrimaryHIBCC0

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
+1(800)827-5262customer-service@shofu.com

Regulatory Flags#

DUNS number
054618202
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
E235DPC0DentaprintDPCDPC2026-04-29
E235DPM0DentaprintDPMDPM2026-04-29
E235DPOM0DentaprintDPOMDPOM2026-04-29
E235DPSG0DentaprintDPSGDPSG2026-04-29
E235DPTIA10DentaprintDPTIA1DPTIA12026-04-29
E235DPTIA2DentaprintDPTIA2DPTIA22026-04-29
E235DPTIBW0DentaprintDPTIBWDPTIBW2026-04-29
04548162224736GlasIonomer FX ULTRA112511252026-04-10
04548162224743GlasIonomer FX ULTRA112611262026-04-10
04548162224750GlasIonomer FX ULTRA112711272026-04-10
04548162224767GlasIonomer FX ULTRA112811282026-04-10
04548162265111VINTAGE Art UniversalP1695P16952026-04-10
04548162267207VINTAGE Art UniversalP0691P06912026-04-10
04548162267214VINTAGE Art UniversalP0693P06932026-04-10
04548162267221VINTAGE Art UniversalP0692P06922026-04-10
04548162267238VINTAGE Art UniversalP0694P06942026-04-10
04548162267245VINTAGE Art UniversalP0695P06952026-04-10
04548162267252VINTAGE Art UniversalP0696P06962026-04-10
04548162267269VINTAGE Art UniversalP0697P06972026-04-10
04548162267276VINTAGE Art UniversalP0698P06982026-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809896990288ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
08809896991056ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
08809896991063ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-15
00810184450030RodinPac-Dent, Inc.EBD2026-05-15
08809896990172ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990189ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990196ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990202ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990219ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990226ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990233ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990240ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990257ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990264ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990271ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990295ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990387ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990400ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990417ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990424ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990431ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990448ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990455ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990462ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990479ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990486ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990493ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990509ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990516ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14
08809896990523ID LIGHTCURE SYSTEMID KOREA CO., LTD.EBD2026-05-14