Elastomeric Impression Material 50ml/bio-cartridge, 2 bio-cartridges/box

GUDID 06970402670115

SHANDONG HUGE DENTAL MATERIAL CORPORATION

Silicone dental impression material

• Primary Device ID: 06970402670115
• NIH Device Record Key: e0634275-82ae-4392-9301-de78919a6751
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elastomeric Impression Material
• Version Model Number: Type 1 (Heavy Body Dispenser-mix Fast Set)
• Catalog Number: 50ml/bio-cartridge, 2 bio-cartridges/box
• Company DUNS: 528184691
• Company Name: SHANDONG HUGE DENTAL MATERIAL 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: true
• 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	06970402670115 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133071

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

On-Brand Devices [Elastomeric Impression Material]

• 06970402675202: Type 0 (Putty Hand-Mix)
• 06970402675196: Type 0 (Putty Hand-Mix)+Type 3 (Light Body)
• 06970402675189: Type 0 (Putty Hand-Mix)+Type 3 (Light Body)
• 06970402675172: Type 0 (Putty Hand-Mix)+Type 3 (Light Body)
• 06970402675165: Type 3 (Light Body)
• 06970402675158: Type 2 (Regular Body)
• 06970402675141: Type 1 (Heavy Body Auto-mix Fast Set)
• 06970402675134: Type 1 (Heavy Body Auto-mix Normal Set)
• 06970402675127: Type 1 (Heavy Body Dispenser-mix Fast Set)
• 06970402675110: Type 1 (Heavy Body Dispenser-mix Normal Set)
• 06970402675103: Type 0 (Bite Registration Dispenser-mix Fast Set)
• 06970402675097: Type 0 (Bite Registration Dispenser-mix Normal Set
• 06970402675080: Type 0 (Putty Auto-Mix)
• 06970402675073: Type 0 (Putty Hand-Mix)
• 06970402675066: Type 0 (Putty Hand-Mix)
• 06970402675059: Type 0 (Putty Hand-Mix)
• 06970402675042: Type 0 (Putty Hand-Mix)
• 06970402674984: Impression kit
• 06970402674977: Impression kit
• 06970402674953: Impression kit
• 06970402670344: Teeth Impression Kit
• 06970402670337: Teeth Impression Kit
• 06970402670320: Teeth Impression Kit
• 06970402670313: Impression kit
• 06970402670214: Type 0 (Putty Hand-Mix)+Type 3 (Light Body)
• 06970402670177: Type 0 (Putty Hand-Mix)+Type 3 (Light Body)
• 06970402670160: Type 0 (Putty Hand-Mix)+Type 3 (Light Body)
• 06970402670153: Type 3 (Light Body)
• 06970402670146: Type 2 (Regular Body)
• 06970402670139: Type 1 (Heavy Body Auto-mix Fast Set)
• 06970402670122: Type 1 (Heavy Body Auto-mix Normal Set)
• 06970402670115: Type 1 (Heavy Body Dispenser-mix Fast Set)
• 06970402670108: Type 1 (Heavy Body Dispenser-mix Normal Set)
• 06970402670092: Type 0 (Bite Registration Dispenser-mix Fast Set)
• 06970402670085: Type 0 (Bite Registration Dispenser-mix Normal Set
• 06970402670078: Type 0 (Putty Auto-Mix)
• 06970402670061: Type 0 (Putty Hand-Mix)
• 06970402670054: Type 0 (Putty Hand-Mix)
• 06970402670047: Type 0 (Putty Hand-Mix)
• 06970402670030: Type 0 (Putty Hand-Mix)
• 06970402670023: Type 0 (Putty Hand-Mix)
• 06970402670016: Type 0 (Putty Hand-Mix)
• 06970402675233: Type 0 (Putty Hand-Mix)
• 06970402675226: Type 0 (Putty Hand-Mix)
• 06970402675912: Type 0 (Putty Hand-Mix)
• 06970402675745: Type 0 (Putty Hand-Mix)