DCI Edge RM5552

GUDID 00810021439266

Rear Mount International, Prep for Durr

DCI International, LLC

Dental delivery system instrument unit, pneumatic

• Primary Device ID: 00810021439266
• NIH Device Record Key: bc1b6dc9-7e41-4a17-996b-866571cdbef1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DCI Edge
• Version Model Number: RM5
• Catalog Number: RM5552
• Company DUNS: 032221423
• Company Name: DCI International, 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: false
• Lot Batch: false
• 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: 5035372445
• Email: regulatory@dcionline.com
• Phone: 5035372445
• Email: regulatory@dcionline.com
• Phone: 5035372445
• Email: regulatory@dcionline.com
• Phone: 5035372445
• Email: regulatory@dcionline.com
• Phone: 5035372445
• Email: regulatory@dcionline.com
• Phone: 5035372445
• Email: regulatory@dcionline.com
• Phone: 5035372445
• Email: regulatory@dcionline.com
• Phone: 5035372445
• Email: regulatory@dcionline.com
• Phone: 5035372445
• Email: regulatory@dcionline.com
• Phone: 5035372445
• Email: regulatory@dcionline.com
• Phone: 5035372445
• Email: regulatory@dcionline.com
• Phone: 5035372445
• Email: regulatory@dcionline.com
• Phone: 5035372445
• Email: regulatory@dcionline.com
• Phone: 5035372445
• Email: regulatory@dcionline.com
• Phone: 5035372445
• Email: regulatory@dcionline.com
• Phone: 5035372445
• Email: regulatory@dcionline.com
• Phone: 5035372445
• Email: regulatory@dcionline.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810021439266 [Primary]

FDA Product Code

• EIA: Unit, Operative Dental

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: 2024-03-19
• Device Publish Date: 2024-03-11

On-Brand Devices [DCI Edge]

• 00810021432380: DCI Edge Over the Patient Auto Dental Unit Series 5
• 00810021432175: DCI Edge Over the Patient Auto Dental Unit Series 4
• 00810021430928: DCI Edge Side Delivery Auto Dental Unit Series 5
• 00810021430898: DCI Edge Side Delivery Auto Dental Unit Series 4
• 00810021430843: DCI Edge Swing Mount with Auto Dental Unit Series 5
• 00810021430775: DCI Edge Swing Mount with Auto Dental Unit Series 4
• 00810021430669: 12 O'clock Cabinet Mount Delivery System
• 00810021430522: Orthodontic Chair
• 00810021430508: Series 4 Dental Chair w/50 Watt Transformer, 230V
• 00810021430492: Series 4 Dental Chair w/50 Watt Transformer
• 00810021430485: Series 5 Dental Chair w/200 Watt Transformer, 230V
• 00810021430478: Series 5 Dental Chair w/200 Watt Transformer
• 00810021430447: Cabinet Mount Series 5 Light
• 00810021430416: Wall Mount Series 5 Light
• 00810021430362: Track Mount Series 5 Light
• 00810021430324: System Mount Series 4 Light
• 00810021430300: Post Mount Series 5 Light
• 00810021430249: Ceiling Mount Series 5 Light
• 00810021430218: Ceiling Mount Series 4 Light
• 00810021430195: Post Mount Series 4 Light
• 00810021430171: Track Mount Series 4 Light
• 00810021430157: Wall Mount Series 4 Light
• 00810021430140: Cabinet Mount Series 4 Light
• 00810021430133: Post Mount Reliance Light
• 00810021430010: System Mount Series 5 Light
• 00810021432526: Edge Automatic Control Cart
• 00810021435268: Ortho Cabinet
• 00810021435275: 12 O'Clock Floor Mount Delivery Series 5
• 00810021439327: Series 5 12 O'Clock Floor Mount, Work Surface Only
• 00810021439297: Rear Mount on Chair w/Cuspidor and Assistants Arm, Series 5
• 00810021439280: Rear Mount on Chair w/Cuspidor, Series 5
• 00810021439273: Rear Mount International, Prep for Canttani
• 00810021439266: Rear Mount International, Prep for Durr
• 00810021439259: Rear Mount Assistant's Package, 1 Syringe, 1 HVE & 1 SE
• 00810021439242: Rear Mount Assistant's Pkg.
• 00810021439235: Rear Mount on Chair, Series 5
• 00810021439228: Rear Mount on Chair w/Cuspidor and Assistants Arm, Series 4
• 00810021439211: Rear Mount on Chair w/Cuspidor, Series 4
• 00810021439204: Rear Mount Assistant's Package, 3 HP
• 00810021439198: Rear Mount on Chair, Series 4
• 00810021438924: Series 4 Automatic Control Cart for 3 HP w/Premium Vacuum
• 00810021438917: Series 4 Automatic Control Cart for 3HP, Self-Contained
• 00810021438825: Series 4 Manual Control Cart for 2 HP
• 00810021438818: Series 4 Manual Control Cart for 2 HP w/Standard Vacuum
• 00810021438801: Series 4 Manual Control Cart for 2 HP w/Premium Vacuum
• 00810021438795: Operatory Support Cart w/Assistant's Package H-Frame
• 00810021438788: Operatory Support Cart w/Assistant's Package U-Frame
• 00810021438771: DCI Edge Over the Patient Euro-Style Dental Unit w/Large PMU, Cuspidor and PMU Assistant, Gray
• 00810021438764: DCI Edge Over the Patient Auto Dental Unit w/Large PMU, Cuspidor and PMU Assistant, Gray
• 00810021438757: DCI Edge Over the Patient Auto Dental Unit w/Large PMU and PMU Assistant Mount, Gray