Sledgehammer 1000546

GUDID H66810005461

HC 100 lb Pwd Lt Fibered

Keystone Industries

Dental appliance fabrication material, cured

• Primary Device ID: H66810005461
• NIH Device Record Key: 0f244f15-9805-4b04-b44c-50bd5ee799f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sledgehammer
• Version Model Number: 1000546
• Catalog Number: 1000546
• Company DUNS: 073503117
• Company Name: Keystone Industries
• 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

Customer Support Contacts

• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com
• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com

Device Dimensions

• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound
• Weight: 100 Pound

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66810005461 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983876

FDA Product Code

• EBI: RESIN, DENTURE, RELINING, REPAIRING, REBASING

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: 2016-09-15

On-Brand Devices [Sledgehammer]

• H66810019751: SC 25 lb Pwd & 4 Qt Liq Kit, Lt Fibered Plus
• H66810019741: SC 5 lb Pwd & 1 Qt Liq Kit, Lt Fibered Plus
• H66810019731: SC 1 lb Pwd & 8 oz Liq Kit, Lt Fibered Plus
• H66810019721: SC 25 lb Pwd Lt Fibered Plus
• H66810019711: SC 5 lb Pwd Lt Fibered Plus
• H66810019701: SC 1 lb Pwd Lt Fibered Plus
• H66810019671: HC 25 lb Pwd & 4 Qt Liq Kit, Lt Fibered Plus
• H66810019661: HC 5 llb Pwd & 1 Qt Liq Kit, Lt Fibered Plus
• H66810019651: HC 1 lb Pwd & 8 oz Liq Kit, Lt Fibered Plus
• H66810019631: HC 25 lb Pwd Lt Fibered Plus
• H66810019621: HC 5 lb Pwd Lt Fibered Plus
• H66810019611: HC 1 lb Pwd Lt Fibered Plus
• H66810005911: 20 Min Qt Liquid
• H66810005901: 20 Min 8 oz Liquid
• H66810005491: SC 25 lb Pwd Lt Fibered
• H66810005481: SC 5 lb Pwd Lt Fibered
• H66810005471: SC 1 lb Pwd Lt Fibered
• H66810005461: HC 100 lb Pwd Lt Fibered
• H66810005451: HC 25 lb Pwd Lt Fibered
• H66810005441: HC 5 lb Pwd Lt Fibered
• H66810005431: HC 1 lb Pwd Lt Fibered
• H66810005411: SC 25 lb Pwd & 4 Qt Liq Kit, Lt Fibered
• H66810005401: SC 5 lb Pwd & 1 Qt Liq Kit, Lt Fibered
• H66810005391: SC 1 lb Pwd & 8 oz Liq Kit, Lt Fibered
• H66810005361: HC 5 llb Pwd & 1 Qt Liq Kit, Lt Fibered
• H66810005351: HC 1 lb Pwd & 8 oz Liq Kit, Lt Fibered
• H66810005231: 1 gal SC Liquid
• H66810005221: SC Quart Liquid
• H66810005211: SC 8 oz Liquid
• H66810005181: 1 gal HC Liquid
• H66810005171: HC Quart Liquid
• H66810005161: HC 8 oz Liquid
• H66810005151: SC 25 lb Pwd Clear
• H66810005141: SC 5 llb Pwd Clear
• H66810005131: SC 1 lb Pwd Clear
• H66810005121: SC 25 lb Pwd Original
• H66810005111: SC 5 llb Pwd Original
• H66810005101: SC 1 lb Pwd Original
• H66810005091: SC 25 lb Pwd Light Red Pink
• H66810005081: SC 5 llb Pwd Light Red Pink
• H66810005071: SC 1 lb Pwd Light Red Pink
• H66810005041: HC 25 lb Pwd Clear
• H66810005031: HC 5 llb Pwd Clear
• H66810005021: HC 1 lb Pwd Clear
• H66810005001: HC 25 lb Pwd Original
• H66810004991: HC 5 llb Pwd Original
• H66810004981: HC 1 lb Pwd Original
• H66810004971: HC 100 lb Pwd Light Red Pink
• H66810004961: HC 25 lb Pwd Light Red Pink
• H66810004951: HC 5 llb Pwd Light Red Pink