SciPharm Gel Etch Dental Conditioner 70-12

GUDID D801SP7012N1

Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 12 grams Green Gel Etch Syringe. Non-Boxed.

SCIENTIFIC PHARMACEUTICALS, INC.

Dental etching solution

• Primary Device ID: D801SP7012N1
• NIH Device Record Key: 71381323-8530-47e1-802a-4dc3f7fa018d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SciPharm Gel Etch Dental Conditioner
• Version Model Number: SP 70-12 N
• Catalog Number: 70-12
• Company DUNS: 096010525
• Company Name: SCIENTIFIC PHARMACEUTICALS, INC.
• 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: true
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-634-3047
• Email: Denise@scipharm.com
• Phone: 800-634-3047
• Email: Denise@scipharm.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 83 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Fahrenheit and 83 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D801SP7012N1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K872569

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-10

On-Brand Devices [SciPharm Gel Etch Dental Conditioner]

• D801SP7014N1: Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 12 gram Blue Gel Et
• D801SP7014B1: Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 12 gram Blue Gel Et
• D801SP70143N1: Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 60 gram Blue Gel Et
• D801SP70143B1: Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 60 gram Blue Gel Et
• D801SP70130N1: Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 3 gram Green Gel Et
• D801SP70130B1: Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 3 gram Green Gel Et
• D801SP7012SB1: Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 12 grams Green Gel
• D801SP7012RB1: Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 12 grams Green Gel
• D801SP7012N1: Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 12 grams Green Gel
• D801SP7012B1: Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 12 grams Green Gel
• D801SP70128B1: Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 60 gram Green Gel E
• D801SP70125SB1: Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 60 gram Green Gel E
• D801SP70125RB1: Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 60 gram Green Gel E
• D801SP70125N1: Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 60 gram Green Gel E
• D801SP70125B1: Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 60 gram Green Gel E
• D801SP701211: Gel Etch is a High Viscosity Enamel Etching Agent for All Bonding Purposes. 2 cc Green Gel Etch