sponge pellets SP

GUDID D798SP1

Sponge applicators for sealants and resins.

RELIANCE ORTHODONTIC PRODUCTS INC

Dental material application tool, single-use

• Primary Device ID: D798SP1
• NIH Device Record Key: 11582721-8f86-4e5f-9b53-dc4ef8ad84df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: sponge pellets
• Version Model Number: SP
• Catalog Number: SP
• Company DUNS: 113170088
• Company Name: RELIANCE ORTHODONTIC PRODUCTS INC
• Device Count: 500
• DM Exempt: true
• 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: false
• 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

Customer Support Contacts

• Phone: 6307734009
• Email: paulgropi@aol.com
• Phone: 6307734009
• Email: paulgropi@aol.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D798SP0 [Unit of Use]
HIBCC	D798SP1 [Primary]

FDA Product Code

• ECP: Instrument, Ligature Tucking, Orthodontic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-09-04

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