Dental City 25-205GR

GUDID D77125205GR1

ICP, INC.

Surgical/medical respirator, single-use

• Primary Device ID: D77125205GR1
• NIH Device Record Key: e092d182-e5da-4da1-a014-e2bcc7a1b68f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dental City
• Version Model Number: 25-205GR
• Catalog Number: 25-205GR
• Company DUNS: 808371371
• Company Name: ICP, INC.
• Device Count: 50
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com
• Phone: 1-800-353-9595
• Email: info@dentalcity.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D77125205GR0 [Unit of Use]
HIBCC	D77125205GR1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133070

FDA Product Code

• FXX: Mask, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Dental City]

• D7714990110: Heavy Body Fast Set VPS
• D7714990100: Monophase Fast Set VPS
• D7714990090: Medium Body Fast Set VPS
• D7714990080: Light Body Fast Set VPS
• D7714990070: Heavy Body Regular Set VPS
• D7714990050: Monophase Regular Set VPS
• D7714990040: Medium Body Regular Set VPS
• D7714990030: Light Body Regular Set VPS
• D7714980080: Fast Set Putty
• D7714980060: Regular Set Putty
• D7714890100: Hard Bite Fast Set Unflavored Bite Registration
• D7714890050: Super Fast Set Flavored Bite Registration
• D7714890040: Fast Set Flavored Bite Registration
• D7714890030: Super Fast Set Unflavored Bite Registration
• D7714890020: Fast Set Unflavored Bite Registration
• D7714890010: Regular Set Unflavored Bite Registration
• D771422750M1: Fluoride varnish
• D771422750BG1: 42-2750BG
• D771412050: Dental City Wintergreen Freeze Spray
• D77125205WH1: Dental City Earloop Masks - White
• D77125205PK1: Dental City Earloop Masks - Pink
• D77125205LV1: Dental City Earloop Mask - Lavender
• D77125205GR1: 25-205GR
• D77125205BL1: Dental City Earloop Mask - Blue
• D771551450: Digital X-Ray Sensor Protector 2.5x10
• D771505780: Tray Sleeve E 11 5/8 x16"
• D771505770: Tray Sleeve A Chayes 11 5/8X14.5
• D771505760: Tray Sleeve F Mini 7.5 x 10.5
• D771505740: Tray Sleeve B Ritter 10.5X14 Perforated Top
• D77150303CL0: Dental City Syringe Sleeves 2.5 X 10 Slide Thru Clear
• D77150303BL1: Dental City Syringe Sleeves 2.5 X 10 Slide Thru Blue
• D77125205BK0: Dental City Earloop Masks Black
• D771252053WH0: Dental City Earloop Masks 4 PLY Super Soft White
• D771252053PU0: Dental City Earloop Masks 4 PLY Super Soft Purple
• D771252053PK0: Dental City Earloop Masks 4 PLY Super Soft Pink
• D771252053OR0: Dental City Earloop Masks 4 PLY Super Soft Orange
• D771252053CB0: Dental City Earloop Masks 4 PLY Super Soft Cobalt Blue
• D771252053BL0: Dental City Earloop Masks 4 PLY Super Soft Blue
• D771252053BK0: Dental City Earloop Masks 4 PLY Super Soft Black
• D771252052PU0: Dental City Earloop Masks Purple
• D771252052FP0: Dental City Earloop Masks Fushcia Pink
• D477116110XS0: USAdvantage Powder Free Latex Exam Gloves X-Small
• D477116110XL0: USAdvantage Powder Free Latex Exam Gloves X-Large
• D477116110SM0: USAdvantage Powder Free Latex Exam Gloves Small
• D477116110MD0: 16-110MD
• D477116110LG0: USAdvantage Powder Free Latex Exam Gloves Large
• D477114715XS0: Helium PF Nitrile Blue Gloves X-Small 300/Box
• D477114715XL0: Helium PF Nitrile Blue Gloves X- Large
• D477114715SM0: Helium PF Nitrile Blue Gloves Small
• D477114715MD0: Helium PF Nitrile Blue Gloves Medium