Obsidian 70-1122-OMB0011

GUDID D745701122OMB00111

Obsidian Milling Block GD 5-Pack W14 TS150 D2

Prismatik Dentalcraft, Inc

Dental appliance fabrication material, ceramic

• Primary Device ID: D745701122OMB00111
• NIH Device Record Key: 1a8b6914-bd36-4fc6-996f-fa21af0e37c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Obsidian
• Version Model Number: 70-1122-OMB0011
• Catalog Number: 70-1122-OMB0011
• Company DUNS: 022761689
• Company Name: Prismatik Dentalcraft, Inc
• Device Count: 5
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com

Device Dimensions

• Width: 14 Millimeter
• Width: 14 Millimeter
• Width: 14 Millimeter
• Width: 14 Millimeter
• Width: 14 Millimeter
• Width: 14 Millimeter
• Width: 14 Millimeter
• Width: 14 Millimeter
• Width: 14 Millimeter
• Width: 14 Millimeter
• Width: 14 Millimeter
• Width: 14 Millimeter
• Width: 14 Millimeter
• Width: 14 Millimeter
• Width: 14 Millimeter
• Width: 14 Millimeter
• Width: 14 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745701122OMB00110 [Unit of Use]
HIBCC	D745701122OMB00111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141788

FDA Product Code

• EIH: POWDER, PORCELAIN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-08-22
• Device Publish Date: 2016-09-23

On-Brand Devices [Obsidian]

• D754544002000: Obsidian Spray Glaze
• D745701181MIL00460: Obsidian Starter Kit
• D745701124SHS00460: Prismatik Universal Low Fusing Ceramic Fluorescent Spray Glaze
• D745701124SHS00450: Prismatik Universal Low Fusing Ceramic Fluorescent Spray Glaze
• D745701124SHS00240: Prismatik Universal Low Fusing Ceramic Fluorescent Spray Glaze
• D745701124SHS00230: Prismatik Universal Low Fusing Ceramic Fluorescent Spray Glaze
• D745701124PUS0095: Obsidian Fluorescent Low Glaze Paste, 5g
• D745701124PUS00460: Prismatik Universal Low Fusing Ceramic Fluorescent Spray Glaze
• D745701124PUS00450: Prismatik Universal Low Fusing Ceramic Fluorescent Spray Glaze
• D745701124PUS00240: Prismatik Universal Low Fusing Ceramic Fluorescent Spray Glaze
• D745701124PUS00230: Prismatik Universal Low Fusing Ceramic Fluorescent Spray Glaze
• D745701122SHS01451: Obsidian Milling Blocks C-Mandrel Variety Pack
• D745701122SHS01011: Obsidian Milling Block 5-Pack W14 C-Mandrel BL4 HS
• D745701122SHS01001: Obsidian Milling Block 5-Pack W14 C-Mandrel BL1 HS
• D745701122SHS00991: Obsidian Milling Block 5-Pack W14 C-Mandrel D3 HS
• D745701122SHS00981: Obsidian Milling Block 5-Pack W14 C-Mandrel D2 HS
• D745701122SHS00971: Obsidian Milling Block 5-Pack W14 C-Mandrel C3 HS
• D745701122SHS00961: Obsidian Milling Block 5-Pack W14 C-Mandrel C2 HS
• D745701122SHS00951: Obsidian Milling Block 5-Pack W14 C-Mandrel C1 HS
• D745701122SHS00941: Obsidian Milling Block 5-Pack W14 C-Mandrel B3 HS
• D745701122SHS00931: Obsidian Milling Block 5-Pack W14 C-Mandrel B2 HS
• D745701122SHS00921: Obsidian Milling Block 5-Pack W14 C-Mandrel B1 HS
• D745701122SHS00911: Obsidian Milling Block 5-Pack W14 C-Mandrel A3.5 HS
• D745701122SHS00901: Obsidian Milling Block 5-Pack W14 C-Mandrel A3 HS
• D745701122SHS00891: Obsidian Milling Block 5-Pack W14 C-Mandrel A2 HS
• D745701122SHS00881: Obsidian Milling Block 5-Pack W14 C-Mandrel A1 HS
• D745701122OMB01631: Obsidian Milling Block GD 5-Pack W14 C-Mandrel BL4
• D745701122OMB01621: Obsidian Milling Block GD 5-Pack W14 C-Mandrel BL1
• D745701122OMB01611: Obsidian Milling Block GD 5-Pack W14 C-Mandrel D3
• D745701122OMB01601: Obsidian Milling Block GD 5-Pack W14 C-Mandrel D2
• D745701122OMB01591: Obsidian Milling Block GD 5-Pack W14 C-Mandrel C3
• D745701122OMB01581: Obsidian Milling Block GD 5-Pack W14 C-Mandrel C2
• D745701122OMB01571: Obsidian Milling Block GD 5-Pack W14 C-Mandrel C1
• D745701122OMB01561: Obsidian Milling Block GD 5-Pack W14 C-Mandrel B3
• D745701122OMB01551: Obsidian Milling Block GD 5-Pack W14 C-Mandrel B2
• D745701122OMB01541: Obsidian Milling Block GD 5-Pack W14 C-Mandrel B1
• D745701122OMB01531: Obsidian Milling Block GD 5-Pack W14 C-Mandrel A3.5
• D745701122OMB01521: Obsidian Milling Block GD 5-Pack W14 C-Mandrel A3
• D745701122OMB01511: Obsidian Milling Block GD 5-Pack W14 C-Mandrel A2
• D745701122OMB01501: Obsidian Milling Block GD 5-Pack W14 C-Mandrel A1
• D745701122OMB00581: Obsidian Milling Block TS150 Variety Pack
• D745701122OMB00570: Obsidian Milling Blocks Trial Kit
• D745701122OMB00141: Obsidian Milling Block GD 5-Pack W14 TS150 BL4
• D745701122OMB00131: Obsidian Milling Block GD 5-Pack W14 TS150 BL1
• D745701122OMB00121: Obsidian Milling Block GD 5-Pack W14 TS150 D3
• D745701122OMB00111: Obsidian Milling Block GD 5-Pack W14 TS150 D2
• D745701122OMB00101: Obsidian Milling Block GD 5-Pack W14 TS150 C3
• D745701122OMB00091: Obsidian Milling Block GD 5-Pack W14 TS150 C2
• D745701122OMB00081: Obsidian Milling Block GD 5-Pack W14 TS150 C1
• D745701122OMB00071: Obsidian Milling Block GD 5-Pack W14 TS150 B3