Young 295830

GUDID 20302730002342

Young Sleeve for Infinity, Infection Control Barrier

YOUNG DENTAL MANUFACTURING I, LLC

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• Primary Device ID: 20302730002342
• NIH Device Record Key: 4aa5b7dc-574a-41be-9a02-5ba5918eb72b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Young
• Version Model Number: 295830
• Catalog Number: 295830
• Company DUNS: 006309355
• Company Name: YOUNG DENTAL MANUFACTURING I, LLC
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com
• Phone: +1(800) 325-1881
• Email: customerservice@younginnovations.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00302730002348 [Primary]
GS1	10302730002345 [Package]; Contains: 00302730002348; Package: Box [400 Units]; In Commercial Distribution
GS1	20302730002342 [Package]; Contains: 00302730002348; Package: Case [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151123

FDA Product Code

• PEM: Dental barriers and sleeves

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: 2022-10-24
• Device Publish Date: 2022-10-16

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• 20302733230100: Young D-Lish EZ-Paks - Contra DPA & Latex Free, Soft, Short, Petite Web Purple Cup & D-Lish Mint
• 20302733212106: Young D-Lish EZ-Paks - Classic DPA & Latex Free, Soft, Short, Petite Web Purple Cup & D-Lish Che
• 10302733210105: Young D-Lish EZ-Paks - Classic DPA & Latex Free, Soft, Short, Petite Web Purple Cup & D-Lish Min
• 10302733200106: Young D-Lish EZ-Paks - Classic DPA & Latex Free, Soft, Short, Traditional Web Purple Cup & D-Lis
• 10302732961060: Young Handpiece Adapter for Disposable Prophy Angles, E-type, Low Speed Attachment
• 10302732960513: Young Elite Flex Prophy Cup, Latex Free, Extra Soft Pink Cup, Screw Type, Bulk Buy
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• 20302732958173: Young DPA Slim Elite Original, Latex Free, Soft, Short, Purple Cup, Screw Type
• 10302732958169: Young DPA Slim Elite Original, Latex Free, Soft, Short, Purple Cup, Screw Type
• 10302732958152: Young DPA Slim Classic Petite Web, Latex Free, Soft, Short, Purple Cup, Screw Type
• 20302732958142: Young DPA Slim Classic Petite Web, Latex Free, Soft, Short, Purple Cup, Screw Type
• 10302732957377: Young INFINITY Cordless Handpiece System
• 10302732957223: Young Pointed Polisher, Latex Free, Firm, Blue Ribbed Exterior, Screw Type, Bulk Buy
• 10302732957216: Young Cordless Handpiece System, White
• 10302732957049: Young Petite Prophy Cup, Latex Free, Firm, Short, Green Web Cup, Screw Type, Bulk Buy
• 10302732956967: Young DPA Slim Classic Petite Web & Slim Contra Elite, Latex Free, Soft, Short, Purple Cup, Samp
• 10302732956875: Young Prophy Paste, Berry, Polish
• 10302732956851: Young Prophy Paste, Mint, Polish
• 10302732956837: Young DPA Classic Petite Web, Latex Free, Soft, Purple Cup
• 10302732956820: Young DPA Contra Petite Web, Latex Free, Soft, Purple Cup
• 10302732956813: Young DPA Classic Elite, Latex Free, Soft, Purple Cup
• 10302732956806: Young DPA Contra Elite, Latex Free, Soft, Purple Cup
• 10302732956394: Young Prophy Paste without Fluoride, Sample Pack in Clamshell - Mint, Berry
• 10302732954734: Young Dentek Prophy Cup, Latex Free, Soft, Regular, Gray Web Cup, Screw Type, Bulk Buy
• 10302732954185: Young Vera Prophy Paste & DPA Vera, Latex Free, Soft Purple Cup, Sample Pack, 6ct
• 20302732953895: Young Vera Prophy Paste, Assorted, Stain Remover, 125ct
• 10302732953881: Young Vera Prophy Paste, Assorted, Polish, 125ct
• 20302732953871: Young Vera Prophy Paste, Arctic Mint, Stain Remover, 125ct
• 20302732953864: Young Vera Prophy Paste, Arctic Mint, Polish, 125ct
• 10302732952686: Young SmartSelect, Selective Polishing Paste - 2 in 1 Stain Remover & Polish, Clamshell
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• 10302732952310: Young SmartSelect, Selective Polishing Paste, Assorted Flavors
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• 10302732950699: Young Centrays, Anatomically Contoured Fluoride Trays, Large, 50 White Upper Trays, 50 Blue Lowe
• 20302732950689: Young Centrays, Anatomically Contoured Fluoride Trays, Medium, 50 White Upper Trays, 50 Blue Low
• 20302732950672: Young Centrays, Anatomically Contoured Fluoride Trays, Small, 50 White Upper Trays, 50 Blue Low
• 10302732950668: Young Centwins, Anatomically Contoured Fluoride Trays - Hinged, Large, 50ct - 13226938
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• 10302732950644: Young Centwins, Anatomically Contoured Fluoride Trays - Hinged, Small, 50ct - 13226936
• 10302732826123: Young Metal Mandrel Right Angle - Latch Type 16mm, Metal, Screw type, CE
• 10302732816124: Young Mandrel Right Angle - Latch Type 16mm, Nickel Plated Brass, Screw type
• 10302732814120: Young Mandrel Right Angle - Latch Type 14mm, Nickel Plated Brass, Screw type
• 10302731777013: Young Rubber Damn Frame Kit, Contoured Adult, Hooks, Balls, 7 tines,(5 1/16 in. X 4 1/8 in.) (12
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