Harvard PremiumSil Putty Soft MaxiMix

GUDID EHAR70837401

Vinylpolysiloxane impression material, Putty Soft, kneadable, MaxiMix, type 0

Harvard Dental International GmbH

Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material Silicone dental impression material

• Primary Device ID: EHAR70837401
• NIH Device Record Key: 82090b83-aad3-4152-afe4-f2e7f2ab016b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harvard PremiumSil Putty Soft MaxiMix
• Version Model Number: 7083740
• Company DUNS: 341553293
• Company Name: Harvard Dental International GmbH
• 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: 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	EHAR70837401 [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: 2018-07-06 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