Harvard Etch

GUDID EHAR70540001

Thixotropic gel containing 37% phosphoric acid

Harvard Dental International GmbH

Dental etching solution

• Primary Device ID: EHAR70540001
• NIH Device Record Key: 5e4a97c2-b1b8-40c9-ae9c-042e6176dfa6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Harvard Etch
• Version Model Number: 7054000
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EHAR70540001 [Primary]

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• 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