The Orthodontic Store 650-500-P

GUDID 10840326406356

Nylon Headgear Case, Pink

Young Innovations, Inc.

Orthodontic extraoral headgear

• Primary Device ID: 10840326406356
• NIH Device Record Key: 32e3e5f8-fd73-4b4a-9c18-1024b0025273
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Orthodontic Store
• Version Model Number: 650-500-P
• Catalog Number: 650-500-P
• Company DUNS: 004193103
• Company Name: Young Innovations, 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: false
• 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: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com
• Phone: +1 (800) 558-6684
• Email: support@youngspecialties.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840326406359 [Primary]
GS1	10840326406356 [Package]; Contains: 00840326406359; Package: Inner Pack [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K961754

FDA Product Code

• DZB: Headgear, extraoral, orthodontic

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: 2022-11-10
• Device Publish Date: 2022-11-02

On-Brand Devices [The Orthodontic Store]

• 10840326406349: Nylon Headgear Case, Black
• 10843471189198: Comfort Hook™ First Molar Weldable Convertible Buccal Tubes, Double, Roth, Upper Left, .022
• 10843471189068: Debnam Weldable Cleat Small Version
• 10843471188610: .022 U/L Std Comb. Weld Size#10
• 10843471188603: .022 U/L Std. Comb. Weld Size#9
• 10843471188382: .022 L/R Std. Weld Size #2
• 10843471188245: .022 U/R Std. Weld Size #1
• 10843471188238: .022 U/L Std. Weld Size #29
• 10843471187996: Anatomical Molar Bands, Upper Left 1St & 2Nd Molars, Size 42.5
• 10843471187989: Anatomical Molar Bands, Upper Left 1St & 2Nd Molars, Size 41.5
• 10843471186975: Anatomical Molar Bands, Lower Left 2Nd Molars, Size 16
• 10843471186524: Anatomical Molar Bands, Lower Left 1St Molars, Size 32
• 10843471186517: Anatomical Molar Bands, Lower Left 1St Molars, Size 31
• 10843471186487: .022 Lower Biband Weld Size#2
• 10843471186388: 022 L/R Std. Dbl. Weld Size#33.0
• 10843471186210: 022 L/L Std. Dbl. Weld Size#33.0
• 10843471186081: 022 U/R Std. Trpl Weld Size#32.5
• 10843471185862: 022 U/R Std. Sngl Weld Size#40.5
• 10843471185855: 022 U/R Std. Sngl Weld Sz#34.0
• 10843471184926: .022 U/L Std. Comb. Weld Size#27 (Welded)
• 10843471184902: .022 U/L Std. Comb. Weld Size#25
• 10843471184889: .022 U/L Std. Comb. Weld Size#24
• 10843471184865: .022 U/L Std. Comb. Weld Size#23
• 10843471184841: .022 U/L Std. Comb. Weld Size#22
• 10843471184827: .022 U/L Std. Comb. Weld Size#21
• 10843471184780: .022 U/L Std. Comb. Weld Size#19
• 10843471184742: .022 U/L Std. Comb. Weld Size#17
• 10843471184728: .022 U/L Std. Comb. Weld Size#16
• 10843471184704: .022 U/L Std. Comb. Weld Size#15
• 10843471184681: .022 U/L Std. Comb. Weld Size#14
• 10843471184667: .022 U/L Std. Comb. Weld Size#13
• 10843471184643: .022 U/L Std. Comb. Weld Size#12
• 10843471184629: .022 U/L Std. Comb. Weld Size#11
• 10843471184605: .022 U/R Std. Sngl Weld Size#31
• 10843471184506: .022 U/R Std. Sngl Weld Size#22 (Welded)
• 10843471184483: .022 U/R Std. Sngl Weld Size#21 (Welded)
• 10843471184469: .022 U/R Std. Sngl Weld Size#20 (Welded)
• 10843471184445: .022 U/R Std. Sngl Weld Size#19 (Welded)
• 10843471184407: .022 U/R Std. Sngl Weld Size#17
• 10843471184384: .022 U/R Std. Sngl Weld Size#15
• 10843471184360: .022 U/R Std. Sngl Weld Size#13
• 10843471184346: .022 U/R Std. Sngl Weld Size#11
• 10843471184322: .022 U/R Std. Sngl Weld Sz#9
• 10843471184308: .022 U/L Std. Sngl Weld Sz#31
• 10843471184292: .022 U/L Std. Sngl Weld Sz#30
• 10843471184278: .022 U/L Std. Sngl Weld Sz#27 (Welded)
• 10843471184261: .022 U/L Std. Sngl Weld Sz#27
• 10843471184254: .022 U/L Std. Sngl Weld Sz#26
• 10843471184247: .022 U/L Std. Sngl Weld Sz#25
• 10843471184230: .022 U/L Std. Sngl Weld Sz#24 (Welded)