A-dec 54.0878.00

GUDID 10194665004507

Air LS Package,S20K,Smart Matic,OTC

A-DEC, INC.

Pneumatic dental power tool system handpiece tip, reusable

• Primary Device ID: 10194665004507
• NIH Device Record Key: ae416501-250e-49aa-8c24-0d33500338d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A-dec
• Version Model Number: 54.0878.00
• Catalog Number: 54.0878.00
• Company DUNS: 009617473
• Company Name: A-DEC, 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: false
• Lot Batch: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10194665004507 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163239

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[10194665004507]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-15
• Device Publish Date: 2022-11-07

On-Brand Devices [A-dec]

• 10194665001414: Toothdryer ASSY-CE
• 10194665002961: Tooth Dryer ASSY
• 10194665001391: Vacuum CONN,W/HVE,5 FT
• 20194665001978: Syringe Tip,Laser Etch
• 10194665000059: A-dec 333 Continental Radius Delivery System
• 10194665005122: Handle,Tooth Dryer
• 10194665005092: Kit,Vacuum Tubings ,11MM + 15MM HVE,Easyflex,Grey 3,63 IN
• 10194665004583: Tip,HVE,90 Degree,Square Ends,Passivated SST,OTC
• 10194665004569: Vacuumm Tubings Kit,11MM + 15MM HVE,Autoclavable,Grey3,52 IN
• 10194665001476: Body,HVE,Autoclavable
• 10194665001421: Dual HVE CVRSN Kit,Unitized HLDR,Cascade,4 POSN,Surf4
• 10194665005306: HDPC,SE,Durr
• 10194665005290: Control Body,Air SE,Pac I
• 10194665005283: HDPC,HVE,Durr
• 10194665005115: Body,HVE,Simulator
• 10194665004965: Dual HVE Kit,15 MM,Gray3,52 IN
• 10194665004958: Dual HVE Kit,11 MM,Gray3,52 IN
• 10194665004941: Dual HVE Kit,STD,Gray3,52 IN
• 10194665004934: Dual HVE Kit,15 MM,Gray3,63 IN
• 10194665004927: Dual HVE Kit,11 MM,Gray3,63 IN
• 10194665004910: Dual HVE Kit,STD,Gray3,63 IN
• 20194665004559: ICX Restore,1 Box,9 Applications
• 10194665002930: Kit,STD HVE/SE ASSY,Dual Vacuum Canister,Easy-Flex,200
• 10194665002879: Vacuum Tubing Kit,INTL,15 MM,2 HVEs,551,Gray3
• 10194665002862: Vacuum Tubing Kit,INTL,15 MM,1 HVE,551,Gray3
• 10194665002855: Vacuum Tubing Kit,INTL,11 MM,2 HVEs,551,Gray3
• 10194665002831: Vacuum Tubing Kit,Domestic,2 HVE,551,Gray3
• 10194665002824: Vacuum Tubing Kit,Domestic,1 HVE,551,Gray3
• 10194665002817: Internal Vacuum Tubings Kit,11 MM,2 HVE,Gray3
• 10194665002800: Internal Vacuum Tubings Kit,11 MM,1 HVE,Gray3
• 10194665002794: INTL Vacuum Tubings Kit,2 HVEs,Gray3
• 10194665002787: INTL Vacuum Tubings Kit,1 HVE,Gray3
• 10194665002770: Domestic Vacuum Tubings Kit,2 HVEs,Gray3
• 10194665002763: Domestic Vacuum Tubings Kit,1 HVE,Gray3
• 10194665002275: Syringe ASST,Mini,TRAD,Non-QD,12 FT,OTC,China
• 10194665002268: Syringe ASSY,Mini,TRAD,Non-QD,12 FT,OTC,INTL
• 10194665002237: Syringe ASSY Mini,TRAD,Non-QD,7 FT,OTC,INTL
• 10194665002190: Syringe ASSY,Mini,TRAD,Non-QD,7 FT,China
• 10194665002183: Syringe ASSY,Mini,TRAD,Non-QD,7 FT,INTL
• 10194665002091: Syringe Head,Mini,Pencil
• 10194665002060: Syringe Head,Mini,TRAD
• 10194665002039: Syringe Head,Pencil
• 10194665002008: Syringe Head ASSY,CE,Autoclavable
• 10194665001964: ASSY,Syringe Tip,Short,Laser Etch
• 10194665001957: ASSY,Syringe Tip,Long,Laser Etch
• 10194665001766: Body,15 MM HVE,Autoclavable
• 10194665001742: Body,Autoclavable SE
• 10194665001506: Body,HVE,Autoclavable
• 10194665005009: CVRSN Kit,Dual HVE,Durr HVE,OTC
• 10194665004996: Dual HVE Kit,EasyFlex,Gray3,63 IN