Ena HRI ® EHTS2

GUDID EMICEHTS20

Ena HRi Ena Soft Color Dentine 5g

MICERIUM SPA

Dental composite resin

• Primary Device ID: EMICEHTS20
• NIH Device Record Key: a60eeed5-7170-4259-9fc5-ce5e40fec352
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ena HRI ®
• Version Model Number: EHTS2
• Catalog Number: EHTS2
• Company DUNS: 436661136
• Company Name: MICERIUM SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Dimensions

• Weight: 7.5 Gram
• Weight: 7.5 Gram
• Weight: 7.5 Gram
• Weight: 7.5 Gram
• Weight: 7.5 Gram
• Weight: 7.5 Gram
• Weight: 7.5 Gram
• Weight: 7.5 Gram
• Weight: 7.5 Gram
• Weight: 7.5 Gram
• Weight: 7.5 Gram
• Weight: 7.5 Gram
• Weight: 7.5 Gram
• Weight: 7.5 Gram
• Weight: 7.5 Gram
• Weight: 7.5 Gram
• Weight: 7.5 Gram

Operating and Storage Conditions

• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 3 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EMICEHTS20 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062906

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-16
• Device Publish Date: 2023-06-08

On-Brand Devices [Ena HRI ®]

• EMICETST1: Ena HRi Stain Flow Transparent 2g Light Curing Composite
• EMICETST0: Ena HRi Stain Flow Transparent 2g Light Curing Composite
• EMICERUE31: Ena HRi Enamel UE3 2.5g Light Curing Composite
• EMICERUE30: Ena HRi Enamel UE3 2.5g Light Curing Composite
• EMICERUE21: Ena HRi Enamel UE2 2.5g Light Curing Composite
• EMICERUE20: Ena HRi Enamel UE2 2.5g Light Curing Composite
• EMICERUE11: Ena HRi Enamel UE1 2.5g Light Curing Composite
• EMICERUE10: Ena HRi Enamel UE1 2.5g Light Curing Composite
• EMICERUD51: Ena HRi Dentin UD5 2.5g Light Curing Composite
• EMICERUD50: Ena HRi Dentin UD5 2.5g Light Curing Composite
• EMICERUD41: Ena HRi Dentin UD4 2.5g Light Curing Composite
• EMICERUD40: Ena HRi Dentin UD4 2.5g Light Curing Composite
• EMICERUD351: Ena HRi Dentin UD3,5 2.5g Light Curing Composite
• EMICERUD350: Ena HRi Dentin UD3,5 2.5g Light Curing Composite
• EMICERUD31: Ena HRi Dentin UD3 2.5g Light Curing Composite
• EMICERUD30: Ena HRi Dentin UD3 2.5g Light Curing Composite
• EMICERUD21: Ena HRi Dentin UD2 2.5g Light Curing Composite
• EMICERUD20: Ena HRi Dentin UD2 2.5g Light Curing Composite
• EMICERUD11: Ena HRi Dentin UD1 2.5g Light Curing Composite
• EMICERUD10: Ena HRi Dentin UD1 2.5g Light Curing Composite
• EMICERUD051: Ena HRi Dentin UD0,5 2.5g Light Curing Composite
• EMICERUD050: Ena HRi Dentin UD0,5 2.5g Light Curing Composite
• EMICERUD01: Ena HRi Dentin UD0 2.5g Light Curing Composite
• EMICERUD00: Ena HRi Dentin UD0 2.5g Light Curing Composite
• EMICERIWS1: Ena HRi Enamel IWS Intensive White Spot 2.5g Light Curing Composite
• EMICERIWS0: Ena HRi Enamel IWS Intensive White Spot 2.5g Light Curing Composite
• EMICERIW1: Ena HRi Enamel IW Intensive White 2.5g Light Curing Composite
• EMICERIW0: Ena HRi Enamel IW Intensive White 2.5g Light Curing Composite
• EMICEREF31: Ena HRi Enamel Function EF3 2.5g Light Curing Composite
• EMICEREF30: Ena HRi Enamel Function EF3 2.5g Light Curing Composite
• EMICEREF21: Ena HRi Enamel Function EF2 2.5g Light Curing Composite
• EMICEREF20: Ena HRi Enamel Function EF2 2.5g Light Curing Composite
• EMICEREF11: Ena HRi Enamel Function EF1 2.5g Light Curing Composite
• EMICEREF10: Ena HRi Enamel Function EF1 2.5g Light Curing Composite
• EMICERBF31: HRi Bio Function Enamel BF3 2,5g Light Curing Composite
• EMICERBF30: Ena HRi Bio Function Enamel BF3 2.5g Light Curing Composite
• EMICERBF21: HRi Bio Function Enamel BF2 2,5g Light Curing Composite
• EMICERBF20: Ena HRi Bio Function Enamel BF2 2.5g Light Curing Composite
• EMICERBF11: HRi Bio Function Enamel BF1 2,5g Light Curing Composite
• EMICERBF10: Ena HRi Bio Function Enamel BF1 2.5g Light Curing Composite
• EMICERBD40: Ena HRi Bio Dentine BD4 2.5g Light Curing Composite
• EMICERBD30: Ena HRi Bio Dentine BD3 2.5g Light Curing Composite
• EMICERBD20: Ena HRi Bio Dentine BD2 2.5g Light Curing Composite
• EMICERBD10: Ena HRi Bio Dentine BD1 2.5g Light Curing Composite
• EMICER3FC1: Ena HRi Function Enamel Kit 2.5g x 3 colors: EREF1, EREF2, EREF3 Posterior Enamel Light Curing
• EMICER3FC0: Ena HRi Function Enamel Kit 2.5g x 3 colors EF1, EF2, EF3 Posterior Enamel Light Curing Composit
• EMICER3FB1: Ena HRi Bio Function Enamel Kit 2.5g x 3 colors: ERBF1, ERBF2, ERBF3 Posterior Enamel Light Cur
• EMICER3FB0: Ena HRi Bio Function Enamel Kit 2.5g x 3 colors BF1, BF2, BF3 Posterior Enamel Light Curing Comp
• EMICER3E1: Ena HRi Enamel Kit 2.5g x 3 colors ERUE1, ERUE2, ERUE3 Light Curing Composite
• EMICER3E0: Ena HRi Enamel Kit 2.5g x 3 colors UE1, UE2, UE3 Light Curing Composite