PEAKOSIL

GUDID 08800026400134

Product Name : Teeth impressions kit This product is a convenience kit including One-time Putty 3EA and 6 dental impression trays. The contents of this kit are all registered in FDA. Its content, One-time Putty is a convenience kit that is changed only in packaging materials from Putty(MSP). These changes don't cause any change in the original functions of Putty. Importer as Retailer is exempt from FDA’S medical device, Establishment Registration, under 21 CFR, 807.65 (e) and (i).

NEOSIL Co., Ltd

Dental impression material kit, single-use

• Primary Device ID: 08800026400134
• NIH Device Record Key: b22f0c3c-0c94-41d7-bf6e-e5df45ee9f98
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PEAKOSIL
• Version Model Number: NS005P-2
• 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	08800026400134 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-13
• Device Publish Date: 2020-01-03

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