R-Pilot Rotary Files TDDRPIL321412

GUDID D716TDDRPIL3214122

R-Pilot 21mm - DEMO

TULSA DENTAL PRODUCTS LLC

Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: D716TDDRPIL3214122
• NIH Device Record Key: 8bdd1651-3c1e-4d5a-860a-2e3e2a60a767
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: R-Pilot Rotary Files
• Version Model Number: TDDRPIL321412
• Catalog Number: TDDRPIL321412
• Company DUNS: 942778564
• Company Name: TULSA DENTAL PRODUCTS LLC
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D716TDDRPIL3214121 [Primary]
HIBCC	D716TDDRPIL3214122 [Unit of Use]

FDA Product Code

• EKS: FILE, PULP CANAL, ENDODONTIC

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-05
• Device Publish Date: 2024-10-28

On-Brand Devices [R-Pilot Rotary Files]

• D716TSTRPIL6254120: R-Pilot 25mm
• D716TSTRPIL6214120: R-Pilot 21mm
• D716TSTRPIL3314120: R-Pilot 31mm
• D716TSTRPIL3254120: R-Pilot 25mm
• D716TSTRPIL3214120: R-Pilot 21mm
• D716TDDRPIL3254122: R-Pilot 25mm
• D716TDDRPIL3214122: R-Pilot 21mm - DEMO