iSmile 45-1533

GUDID 20816419020287

Earloop Mask Level 3 Blue

Ismile Dental Products, Inc.

Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use Surgical/medical face mask, non-antimicrobial, single-use

• Primary Device ID: 20816419020287
• NIH Device Record Key: 01b8c1cb-7211-41e0-ad22-4c011bc069a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iSmile
• Version Model Number: 45-1533
• Catalog Number: 45-1533
• Company DUNS: 016765988
• Company Name: Ismile Dental Products, Inc.
• Device Count: 40
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 916-928-0359
• Email: info@ismiledp.com
• Phone: 916-928-0359
• Email: info@ismiledp.com
• Phone: 916-928-0359
• Email: info@ismiledp.com
• Phone: 916-928-0359
• Email: info@ismiledp.com
• Phone: 916-928-0359
• Email: info@ismiledp.com
• Phone: 916-928-0359
• Email: info@ismiledp.com
• Phone: 916-928-0359
• Email: info@ismiledp.com
• Phone: 916-928-0359
• Email: info@ismiledp.com
• Phone: 916-928-0359
• Email: info@ismiledp.com
• Phone: 916-928-0359
• Email: info@ismiledp.com
• Phone: 916-928-0359
• Email: info@ismiledp.com
• Phone: 916-928-0359
• Email: info@ismiledp.com
• Phone: 916-928-0359
• Email: info@ismiledp.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816419020283 [Primary]
GS1	20816419020287 [Unit of Use]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-29
• Device Publish Date: 2023-06-21

On-Brand Devices [iSmile]

• 10816419023120: VP Patient Bib 2-Ply Paper + 1-Ply Poly 13" x 18" Teal
• 20816419023110: Saliva Ejector Clear with White Tip
• 20816419023080: Earloop Mask Level 3 Black
• 10816419022543: VP Patient Cups Plastic 5 oz Teal
• 10816419022536: VP Patient Cups Plastic 5 oz Pink
• 10816419022529: VP Patient Cups Plastic 5 oz White
• 10816419022512: VP Patient Cups Plastic 5 oz Lavender
• 10816419022505: VP Patient Cups Plastic 5 oz Green
• 10816419022499: VP Patient Cups Plastic 5 oz Blue
• 10816419022482: Sterilization Pouch 2-3/4" x 9" Bulk
• 10816419022178: Isolation Gown Tie Back with Knit Cuff Yellow
• 10816419022161: Isolation Gown Tie Back with Knit Cuff White
• 10816419022154: Isolation Gown Tie Back with Knit Cuff Pink
• 10816419022147: Isolation Gown Tie Back with Knit Cuff Green
• 10816419022130: Isolation Gown Tie Back with Knit Cuff Blue
• 10816419022123: Isolation Gown Tie Back with Elastic Cuff Yellow
• 10816419022116: Isolation Gown Tie Back with Elastic Cuff White
• 10816419022109: Isolation Gown Tie Back with Elastic Cuff Green
• 10816419022093: Isolation Gown Tie Back with Elastic Cuff Pink
• 10816419022086: Isolation Gown Tie Back with Elastic Cuff Blue
• 20816419022076: X-Ray Head Sleeve 15" x 26"
• 20816419022069: Light Handle Cover 4" x 5-3/4"
• 20816419022052: Tray Sleeve Size F 7-1/2" x 10-1/2"
• 20816419022045: Tray Sleeve Size C 11-5/8" x 16"
• 20816419022038: Tray Sleeve Size B 10-1/2" x 14"
• 20816419022021: Chair Sleeve Full 29" x 80"
• 20816419022014: Chair Sleeve Half 27-1/2" x 24"
• 20816419022007: Curing Light Sleeve 13-1/2" x 3-1/4" 3/4" Tip
• 20816419021994: Curing Light Sleeve 13-1/2" x 2" 3/4" Tip
• 20816419021987: Air/Water Syringe Sleeve 2-1/2" x 10" Clear
• 20816419021970: Handpiece Sleeve 1-1/2" x 8" Clear
• 20816419021963: Handpiece Sleeve 1" x 8" Clear
• 20816419021956: Barrier Film 4" x 6" Clear
• 20816419021949: Barrier Film 4" x 6" Blue
• 20816419021932: Bite Tray Disposable Assortment
• 20816419021925: Bite Tray Disposable Full Arch
• 20816419021918: Bite Tray Disposable Sideless Posterior
• 20816419021901: Bite Tray Disposable Quadrant
• 20816419021895: Bite Tray Disposable Posterior
• 20816419021888: Bite Tray Disposable Anterior
• 20816419021871: Digital Sensor Cover 2-1/2" x 10"
• 20816419021864: Digital Sensor Cover 1-3/8" x 8"
• 20816419021857: Digital Sensor Cover 1-5/8" x 8"
• 20816419021840: Surgical Aspirator Tip 1/16" Tip Blue
• 20816419021833: Surgical Aspirator Tip 1/8" Tip White
• 20816419021826: Surgical Aspirator Tip 1/4" Tip Green
• 20816419021819: VP Impression Tray Perforated #7 Anterior Upper
• 20816419021802: VP Impression Tray Perforated #9 Upper Right Lower Left
• 20816419021796: VP Impression Tray Perforated #8 Upper Left Lower Right
• 20816419021789: VP Impression Tray Perforated #4 Small Lower