IQ Dental Supply

GUDID 00816519021524

ZAP-PIT & FISSURE SEALANT LC WITH ACP 4-PACK

IQ DENTAL SUPPLY LLC

Dental pit/fissure sealant

• Primary Device ID: 00816519021524
• NIH Device Record Key: 26a8bd26-e3af-4394-afb9-136d3d80a5d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IQ Dental Supply
• Version Model Number: ZAP-PFSCACP
• Company DUNS: 830702846
• Company Name: IQ DENTAL SUPPLY 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 32 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816519021524 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033751

FDA Product Code

• EBC: Sealant, Pit And Fissure, And Conditioner

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: 2018-07-06
• Device Publish Date: 2016-09-19

Devices Manufactured by IQ DENTAL SUPPLY LLC

• 00816519020732 - IQ Dental: 2019-11-08 IQ Dental Self Seal Sterilization Pouches 3.5X9 Box/200
• 00816519020749 - IQ Dental: 2019-11-08 IQ Dental Self Seal Sterilization Pouches 5.25X10 Box/200
• 00816519020756 - IQ Dental: 2019-11-08 IQ Dental Self Seal Sterilization Pouches 3.5X6.5 Box/200
• 00816519020763 - IQ Dental: 2019-11-08 IQ Dental Self Seal Sterilization Pouches 2.75X10 Box/200
• 00816519021319 - IQ Dental: 2018-11-22 Aspirating Syringe Astra Type 1.8cc
• 00816519021326 - IQ Dental: 2018-11-22 Aspirating Syringe C-W Type 1.8cc
• 00816519021333 - IQ Dental: 2018-11-22 Aspirating Syringe C-W Type 1.8cc
• 00816519020008 - IQ Dental: 2018-07-06 IQDENT ZAP100M MICROHYBRID 4.5G SYR A1