FDA.reportPublic FDA data

Eco-S

Primary DI
08809254451802
Brand
Eco-S
Company
VERICOM CO., LTD.
Model
ES105-K000
Device description
Resin-base Pit and Fissure sealant ; Eco-s 1.2ml x 2 syringes, DenFil Etchant-37 1.5g x 2 syringes
Published
2016-11-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBCSealant, Pit And Fissure, And Conditioner
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2
EBFMaterial, Tooth Shade, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809254451802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809254451802088092544518028809254451802

GMDN Terms#

Term, Definition table
TermDefinition
Dental unfilled resin sealantA non-sterile, resin-based dental material intended for professional use as a sealant for pit/fissure sealing and/or restorative composite resin sealing, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of an unfilled dimethacrylate 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius27 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+82314412881vericom@vericom.co.kr

Regulatory Flags#

DUNS number
689698269
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
08800123819730Well-Root PTWT225-SE002025-11-27
08800123819747Well-Root PTWT202-KE002025-11-27
08800123819754Well-Root PTWT201-EE002025-11-27
08809254459402Well-Root PTWT225-S0002025-11-27
08809254459419Well-Root PTWT202-K0002025-11-27
08809254453776Vonflex S PuttyVF305-S0002023-08-17
08809254451604DenFil Etchant-37ET125-B0002016-11-01
08809254451635DenFil Etchant-37ET115-E0002016-11-01
08809254451666DenFil Etchant-37ET105-R0002016-11-01
08809254451697DenFil Etchant-37ET103-R0002016-11-01
08809254451703DenFil Etchant-37ET136-K0002016-11-01
08809254451710DenFil Etchant-37ET130-B0002016-11-01
08809254451741DenFil Etchant-37ET101-EC002016-11-01
08809254452434DenFil Etchant-37ET148-K0002016-11-01
08809254454360DenFil Etchant-37ET105-S0002016-11-01
08809254450409DenFil DF104-A0002016-11-01
08809254450416DenFilDF104-B0002016-11-01
08809254450423DenFilDF104-C0002016-11-01
08809254450966DenFilDF205-A0002016-11-01
08809254458528MAZIC D SGSG425-S0002025-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208006162SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006179SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006186SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006193SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006209SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006216SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006223SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006230SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006247SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006254SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006261SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006278SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006285SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006292SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006308SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
07615208006315SR NexcoIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBF2022-08-22
EMICEHR6T1Ena HRI ®MICERIUM SPAEBF2021-12-09
EMICEHFUD61Ena HFO ®MICERIUM SPAEBF2021-12-01
ESDG2320491Capo Natural Incisal medium, 4 gSchütz Dental GmbHEBC2016-11-08
ESDG2320491Capo Natural Incisal medium, 4 gSchütz Dental GmbHEBF2016-11-08
ESDG2321121Capo Slow Flow capsules A 1, 20 x 0.25Schütz Dental GmbHEBC2016-11-08
ESDG2321121Capo Slow Flow capsules A 1, 20 x 0.25Schütz Dental GmbHEBF2016-11-08
ESDG2321131Capo Slow Flow capsules A 2, 20 x 0.25Schütz Dental GmbHEBC2016-11-08
ESDG2321131Capo Slow Flow capsules A 2, 20 x 0.25Schütz Dental GmbHEBF2016-11-08
ESDG2321141Capo Slow Flow capsules A 3, 20 x 0.25Schütz Dental GmbHEBC2016-11-08
ESDG2321141Capo Slow Flow capsules A 3, 20 x 0.25Schütz Dental GmbHEBF2016-11-08
ESDG2321151Capo Slow Flow capsules clear, 20 x 0.25Schütz Dental GmbHEBC2016-11-08
ESDG2321151Capo Slow Flow capsules clear, 20 x 0.25Schütz Dental GmbHEBF2016-11-08
ESDG2321221Capo Hybrid A 3, 0.3 gSchütz Dental GmbHEBC2016-11-08
ESDG2321221Capo Hybrid A 3, 0.3 gSchütz Dental GmbHEBF2016-11-08