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Eco-S

FDA UDI

Class II (US FDA UDI)

by Vericom Co., Ltd.

Identity

Trade Name
Eco-S FDA UDI
Generic Name
Dental unfilled resin sealant FDA UDI
Device Name
Resin-base Pit and Fissure sealant ; Eco-s 1.2ml x 2 syringes, DenFil Etchant-37 1.5g x 2 syringes FDA UDI
Model / Reference
ES105-K000 FDA UDI
Description
Resin-base Pit and Fissure sealant ; Eco-s 1.2ml x 2 syringes, DenFil Etchant-37 1.5g x 2 syringes FDA UDI

Identifiers

Primary DI / UDI-DI
08809254451802 FDA UDI
FDA Product Code
EBF FDA UDI
EBC FDA UDI
GMDN Term
Dental unfilled resin sealant FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
872.3765 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Dental etching solutionDental unfilled resin sealant

Eco-S by Vericom Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Dental unfilled resin sealant.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vericom Co., Ltd.

Sources (1)

  • FDA UDI 623deee7-2519-4a5c-810b-046f2dab28bc 35 fields · synced Jun 8, 2026