IQ Dental

GUDID 00816519020022

IQDENT ZAP100M MICROHYBRID 4.5 SYR A3

IQ DENTAL SUPPLY LLC

Dental composite resin

• Primary Device ID: 00816519020022
• NIH Device Record Key: fadd69f6-588e-4209-8660-438e49a7b928
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IQ Dental
• Version Model Number: FP-IQDENT-003
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816519020022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K946307

FDA Product Code

• EBF: Material, Tooth Shade, Resin

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

On-Brand Devices [IQ Dental]

• 00816519021630: IQ DENTAL DYNAMIC 380 MONOPHASE FAST SET REFILL KIT
• 00816519021616: IQ DENTAL DYNAMIC 380 HEAVY BODY FAST SET REFILL KIT
• 00816519021593: IQ DENTAL ALGINATE SUBSTITUTE 50ML REGULAR SET
• 00816519021579: IQ DENTAL ALGINATE SUBSTITUTE 50ML FAST SET
• 00816519021555: ZAP-CALCIUM HYDROXIDE CAVITY LINER- DENTIN SHADE
• 00816519021548: ZAP-CALCIUM HYDROXIDE CAVITY LINER- IVORY SHADE
• 00816519021531: ZAP-PIT & FISSURE SEALANT LC WITH FLUORIDE
• 00816519021517: IQ Dental Clear Bite 5 pack with 6 Mixers
• 00816519021500: IQ Dental Dynamic 380 Monophase Regular Set Refill Kit
• 00816519021494: IQ Dental Alginate Substitute 380ML Fast Set Refill Kit Master Carton
• 00816519021371: Temporary Crown & Bridge Materials Shade B1 w/10 tips
• 00816519021364: NRG Temporary Crown & Bridge Materials Shade A3.5 with 10 tips
• 00816519021357: NRG Temporary Crown & Bridge Materials Shade A2 with 10 tips
• 00816519021340: NRG Temporary Crown & Bridge Materials Shade A1 with 10 tips
• 00816519021333: Aspirating Syringe C-W Type 1.8cc
• 00816519021326: Aspirating Syringe C-W Type 1.8cc
• 00816519021319: Aspirating Syringe Astra Type 1.8cc
• 00816519021302: IQ Dental Adhesive 10ML Bottle
• 00816519021296: IQ Dental Putty Regular Set Kit
• 00816519021289: IQ Dental Putty Fast Set Kit
• 00816519021272: IQ Dental Bite Super Fast Set 2 pack with 6 Mixers
• 00816519021258: IQ Dental Bite Regular Set 2 pack with 6 Mixers
• 00816519021234: IQ Dental Bite Fast Set 2 Pack with 6 Mixers
• 00816519021210: IQ Dental Bite Super Fast Set Mint Choc Chip 2 pack with 6 Mixers
• 00816519021197: IQ Dental Bite Fast Set Mint Choc Chip 2 Pack with 6 Mixers
• 00816519021173: IQ Dental Hard Bite Fast Set 2 Pack with 6 Mixers
• 00816519021159: IQ Dental Bite Fast Set Cartridge Only Bulk Pack
• 00816519021135: IQ Dental CAD-CAM Bite 2 pack with 6 Mixers
• 00816519021098: IQ Dental Alginate Substitute 380ML Fast Set Starter Kit Master Carton
• 00816519021074: IQ Dental Alginate Substitute Fast Set
• 00816519021050: IQ Dental SHM Monophase Regular Set
• 00816519021036: IQ Dental SHM Monophase Fast Set
• 00816519021012: IQ Dental Dynamic 380 Monophase Regular Set Starter Kit
• 00816519020985: IQ Dental SHM Heavy Body Regular Set
• 00816519020961: IQ Dental SHM Heavy Body Fast Set Cartridge Only Bulk Pack
• 00816519020947: IQ Dental SHM Heavy Body Fast Set
• 00816519020923: IQ Dental Dynamic 380 Heavy Body Regular Set Starter Kit
• 00816519020909: IQ Dental Dynamic 380 Heavy Body Regular Set Refill Kit
• 00816519020886: IQ Dental SHM Medium Body Regular Set 4 Pack
• 00816519020862: IQ Dental SHM Medium Body Fast Set 4 Pack
• 00816519020848: IQ Dental SHM Light Body Regular Set Cartridge only Bulk Pack
• 00816519020824: IQ Dental SHM Light Body Regular Set 4 pack
• 00816519020800: IQ Dental SHM Light Body Fast Set Cartridge Only Bulk Pack
• 00816519020787: IQ Dental SHM Light Body Fast Set 4 pack
• 00816519020770: IQ Dental SHM Light Body Fast Set 4 pack
• 00816519020763: IQ Dental Self Seal Sterilization Pouches 2.75X10 Box/200
• 00816519020756: IQ Dental Self Seal Sterilization Pouches 3.5X6.5 Box/200
• 00816519020749: IQ Dental Self Seal Sterilization Pouches 5.25X10 Box/200
• 00816519020732: IQ Dental Self Seal Sterilization Pouches 3.5X9 Box/200
• 00816519020718: IQDENT DUAL CURE CORE B.U. 2-9G SYR KIT