Harvard PremiumSil Mono

GUDID EHAR70837211

Vinylpolysiloxane impression material, super hydrophilic, monophase, type 2

Harvard Dental International GmbH

Silicone dental impression material

• Primary Device ID: EHAR70837211
• NIH Device Record Key: 9faab238-4665-42a9-8677-4a8f052e12d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harvard PremiumSil Mono
• Version Model Number: 7083721
• Company DUNS: 341553293
• Company Name: Harvard Dental International GmbH
• Device Count: 2
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +493099289780
• Email: info@harvard-dental-international.de
• Phone: +493099289780
• Email: info@harvard-dental-international.de
• Phone: +493099289780
• Email: info@harvard-dental-international.de
• Phone: +493099289780
• Email: info@harvard-dental-international.de
• Phone: +493099289780
• Email: info@harvard-dental-international.de
• Phone: +493099289780
• Email: info@harvard-dental-international.de
• Phone: +493099289780
• Email: info@harvard-dental-international.de
• Phone: +493099289780
• Email: info@harvard-dental-international.de
• Phone: +493099289780
• Email: info@harvard-dental-international.de
• Phone: +493099289780
• Email: info@harvard-dental-international.de
• Phone: +493099289780
• Email: info@harvard-dental-international.de
• Phone: +493099289780
• Email: info@harvard-dental-international.de

Operating and Storage Conditions

• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	7083721 [Unit of Use]
HIBCC	EHAR70837211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012767

FDA Product Code

• ELW: Material, Impression

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

Devices Manufactured by Harvard Dental International GmbH

• EHAR70837011 - Harvard PremiumSil Light: 2018-07-06 Vinylpolysiloxane impression material, super hydrophilic, light bodied, type 3
• EHAR70837021 - Harvard PremiumSil Light Fast: 2018-07-06 Vinylpolysiloxane impression material, super hydrophilic, light bodied, type 3
• EHAR70837111 - Harvard PremiumSil Medium: 2018-07-06 Vinylpolysiloxane impression material, super hydrophilic, medium bodied, type 3
• EHAR70837121 - Harvard PremiumSil Medium Fast: 2018-07-06 Vinylpolysiloxane impression material, super hydrophilic, medium bodied, type 3
• EHAR70837211 - Harvard PremiumSil Mono: 2018-07-06Vinylpolysiloxane impression material, super hydrophilic, monophase, type 2
• EHAR70837211 - Harvard PremiumSil Mono: 2018-07-06 Vinylpolysiloxane impression material, super hydrophilic, monophase, type 2
• EHAR70837221 - Harvard PremiumSil Mono Fast: 2018-07-06 Vinylpolysiloxane impression material, super hydrophilic, monophase, type 2
• EHAR70837311 - Harvard PremiumSil Heavy: 2018-07-06 Vinylpolysiloxane impression material, super hydrophilic, heavy bodied, type 2
• EHAR70837321 - Harvard PremiumSil Heavy Fast: 2018-07-06 Vinylpolysiloxane impression material, super hydrophilic, heavy bodied, type 2