Sledgehammer 1000510
GUDID H66810005101
SC 1 lb Pwd Original
Keystone Industries
Dental appliance fabrication material, cured| Primary Device ID | H66810005101 |
| NIH Device Record Key | 914497f8-8969-44d9-ade1-fa7c9de0b708 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sledgehammer |
| Version Model Number | 1000510 |
| Catalog Number | 1000510 |
| 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 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com | |
| Phone | +1(800)333-3131 |
| tschwear@keystoneind.com |
Device Dimensions
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
| Weight | 0.45 Kilogram |
| Weight | 1 Pound |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H66810005101 [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 |
Trademark Results [Sledgehammer]
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