PEAKOSIL

GUDID 18800026400070

Product Name : Start Kit This original PEAKOSIL Start Kit(NSSK) is a kit including PEAKOSIL Light Body 2 EA, PEAKOSIL Putty 1 EA, Yellow Mix Tip 6 EA & Intra Oral Tip 6 EA. The contents of this kit are all registered in FDA.

NEOSIL Co., Ltd

Dental impression material kit, single-use

• Primary Device ID: 18800026400070
• NIH Device Record Key: 8d743fc1-b425-4017-9e77-3e4aeb48c146
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEAKOSIL
• Version Model Number: NSSK
• Company DUNS: 690409169
• Company Name: NEOSIL Co., Ltd
• 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: true
• Device Combination Product: false
• Single Use: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800026400073 [Primary]
GS1	18800026400070 [Package]; Contains: 08800026400073; Package: Carton [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152180

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: 4
• Public Version Date: 2020-01-03
• Device Publish Date: 2017-09-21

On-Brand Devices [PEAKOSIL]

• 08800026400134: Product Name : Teeth impressions kit This product is a convenience kit including One-time Putty
• 08800026400127: Product Name: One-time Putty This product is a convenience kit of Putty(MSP). This product chang
• 08800026400103: Product Name: Heavy Body Tube
• 18800026400094: Product Name: Light Body Fast Set
• 18800026400087: Product Name: Heavy Body Fast Set
• 18800026400070: Product Name : Start Kit This original PEAKOSIL Start Kit(NSSK) is a kit including PEAKOSIL Ligh
• 18800026400063: Product Name: Start Kit This product is a customized Start Kit that one content of the kit was r
• 08800026400042: Product Name: Putty This product has another model number, NS005P which is registered in other c
• 08800026400035: Product Name: Bite This product has another model number, NS011C which is registered in other co
• 18800026400025: Product Name: Monophase This product has another model number, NS024C.
• 18800026400018: Product Name: Light Body
• 08800026400004: Product Name: Heavy Body