Endodontic Hand Instruments 06328015R

GUDID D80906328015R0

K-File Size 015 28mm

ROYDENT DENTAL PRODUCTS INC

Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: D80906328015R0
• NIH Device Record Key: 58197940-8e55-4b86-863a-b5f4144f644e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Endodontic Hand Instruments
• Version Model Number: 06328015R
• Catalog Number: 06328015R
• Company DUNS: 131487225
• Company Name: ROYDENT DENTAL PRODUCTS INC
• Device Count: 6
• 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: 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	D80906328015R0 [Unit of Use]
HIBCC	D80906328015R1 [Primary]

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: 2022-11-17
• Device Publish Date: 2022-11-09

On-Brand Devices [Endodontic Hand Instruments]

• D80907321010R0: HEDSTROM FILES 21MM 10
• D80907321008R0: HEDSTROM FILES 21MM 08
• D80905331025R0: K-Reamer Size 025 31mm
• D80905331020R0: K-Reamer Size 020 31mm
• D80905331015R0: K-Reamer Size 015 31mm
• D80905331010R0: K-Reamer Size 010 31mm
• D80905331008R0: K-Reamer Size 008 31mm
• D80905331006R0: K-Reamer Size 006 31mm
• D80905325170R0: K-Reamer Size 090-110 25mm
• D80905325060R0: K-Reamer Size 060 25mm
• D80905325050R0: K-Reamer Size 050 25mm
• D80905325040R0: K-Reamer Size 040 25mm
• D80905325035R0: K-Reamer Size 035 25mm
• D80905325030R0: K-Reamer Size 030 25mm
• D80905325025R0: K-Reamer Size 025 25mm
• D80905325020R0: K-Reamer Size 020 25mm
• D80905325015R0: K-Reamer Size 015 25mm
• D80905325010R0: K-Reamer Size 010 25mm
• D80905325008R0: K-Reamer Size 008 25mm
• D80905325006R0: K-Reamer Size 006 25mm
• D80905321050R0: K-Reamer Size 050 21mm
• D80905321040R0: K-Reamer Size 040 21mm
• D80905321035R0: K-Reamer Size 035 21mm
• D80905321030R0: K-Reamer Size 030 21mm
• D80905321025R0: K-Reamer Size 025 21mm
• D80905321020R0: K-Reamer Size 020 21mm
• D80905321015R0: K-Reamer Size 015 21mm
• D80905321010R0: K-Reamer Size 010 21mm
• D80905321008R0: K-Reamer Size 008 21mm
• D80905321006R0: K-Reamer Size 006 21mm
• D80906319008R0: K-File Size 008 19mm
• D80906319006R0: K-File Size 006 19mm
• D80907331170R0: HEDSTROM FILES 31MM 90-110
• D80907331165R0: HEDSTROM FILES 31MM 45-80
• D80907331160R0: HEDSTROM FILES 31MM 15-40
• D80907331155R0: HEDSTROM FILES 31MM 08-10
• D80907331080R0: HEDSTROM FILES 31MM 80
• D80907331070R0: HEDSTROM FILES 31MM 70
• D80907331060R0: HEDSTROM FILES 31MM 60
• D80907331055R0: HEDSTROM FILES 31MM 55
• D80907331050R0: HEDSTROM FILES 31MM #50
• D80907331045R0: HEDSTROM FILES 31MM 45
• D80907331040R0: HEDSTROM FILES 31MM 40
• D80907331035R0: HEDSTROM FILES 31MM 35
• D80907331030R0: HEDSTROM FILES 31MM 30
• D80907331025R0: HEDSTROM FILES 31MM 25
• D80907331020R0: HEDSTROM FILES 31MM 20
• D80907331015R0: HEDSTROM FILES 31MM 15
• D80907331010R0: HEDSTROM FILES 31MM 10
• D80907331008R0: HEDSTROM FILES 31MM 08