IMPRESS-RITE 380 IMP-7005

GUDID 00818524020646

M&S DENTAL IMPRESS-RITE 380 MONOPHASE REGULAR SET STARTER KIT

CROWN DELTA CORPORATION

Silicone dental impression material

• Primary Device ID: 00818524020646
• NIH Device Record Key: a73e59d4-3726-49fc-bcf5-3cc1cf3ac144
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: IMPRESS-RITE 380
• Version Model Number: IMP-7005
• Catalog Number: IMP-7005
• Company DUNS: 030479000
• Company Name: CROWN DELTA CORPORATION
• 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: false
• 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 0 Degrees Fahrenheit and 73 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 73 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818524020646 [Primary]
GS1	10818524020643 [Package]; Package: KIT [1 Units]; In Commercial Distribution
GS1	20818524020640 [Package]; Contains: 10818524020643; Package: CASE [8 Units]; In Commercial Distribution

FDA Product Code

• ELW: Material, Impression

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: 2020-02-24
• Device Publish Date: 2017-07-05

Devices Manufactured by CROWN DELTA CORPORATION

• 00818524020714 - EVOLVE KoR: 2023-09-29 EVOLVE KoR LIGHT BODY SHM FAST SET CARTRIDGE
• 00818524020707 - IMPRESS-RITE HP-MIXING TIPS: 2020-12-30 M&S DENTAL IMPRESS-RITE HP TEMPORARY CEMENT MIXING TIP
• 00818524020684 - IMPRESS-RITE T-MIXING TIPS: 2020-12-22 M&S DENTAL CORE MATERIAL T-MIXER BROWN 1:1 BLUNT END 20 PER BAG
• 00818524020646 - IMPRESS-RITE 380: 2020-02-24M&S DENTAL IMPRESS-RITE 380 MONOPHASE REGULAR SET STARTER KIT
• 00818524020646 - IMPRESS-RITE 380: 2020-02-24 M&S DENTAL IMPRESS-RITE 380 MONOPHASE REGULAR SET STARTER KIT
• 10818524020629 - IMPRESS-RITE: 2020-02-18 M&S DENTAL IMPRESS-RITE 380 HEAVY BODY REGULAR SET
• 10818524020605 - IMPRESS-RITE T-MIXING TIPS: 2020-02-12 M&S DENTAL IMPRESS-RITE T-MIXERS C&B BLUE ORANGE 25 PER BAG
• 00818524020523 - IMPRESS-RITE HP MIXING TIPS: 2020-02-06 M&S DENTAL IMPRESS-RITE C&B BLUE ORANGE 25 PER BAG
• 10818524020377 - IMPRESS-RITE T-MIXING TIPS: 2019-11-06 M&S DENTAL IMPRESS-RITE GREEN T-MIXERS (6.5MM) 48/BAG