Ultimate Comfort Smart P

GUDID ERICUCSP00110

Ritter Concept GmbH

Dental delivery system

• Primary Device ID: ERICUCSP00110
• NIH Device Record Key: caef11ca-cfda-4551-83cc-812c82be36f6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ultimate Comfort Smart P
• Version Model Number: UCSP00110
• Company DUNS: 330153086
• Company Name: Ritter Concept GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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
HIBCC	ERICUCSP00110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161734

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: 2024-08-07
• Device Publish Date: 2024-07-30

Devices Manufactured by Ritter Concept GmbH

• ERICCLC000110 - Contact Lite Comfort: 2024-08-07
• ERICCW0000110 - Contact World: 2024-08-07
• ERICUC0000110 - Ultimate Comfort: 2024-08-07
• ERICUCS000110 - Ultimate Comfort Smart: 2024-08-07
• ERICUCSP00110 - Ultimate Comfort Smart P: 2024-08-07
• ERICUCSP00110 - Ultimate Comfort Smart P: 2024-08-07
• ERICEH500000 - Excom hybrid: 2024-02-20
• ERICRA72D000 - RA: 2024-02-20
• ERICRA73D000 - RA: 2024-02-20