Versacryl 1014016
GUDID H66810140161
Acrylic SC Hardener Liquid 1 Qt
Keystone Industries
Dental appliance fabrication material, cured| Primary Device ID | H66810140161 |
| NIH Device Record Key | 578bc8e9-e183-48d8-be64-6e6889924158 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Versacryl |
| Version Model Number | 1014016 |
| Catalog Number | 1014016 |
| 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 |
Device Dimensions
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
| Total Volume | 1 Quart |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | H66810140161 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K012882
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 | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-15 |
On-Brand Devices [Versacryl]
| H66810140391 | SC Reline Intro Kit, 1-50g pink Pwd, 1-60 ml premix Liq |
| H66810140341 | HC Reline Kit, 2-50 g Pink Pwd. 2-60 ml pre-mix Liq. |
| H66810140331 | SC Reline Kit, 2-50 g Pink Pwd. 2-60 ml pre-mix Liq. |
| H66810140321 | HC Lab Kit, 2-50g Pwd, 1-60 ml Liq. hardener, 1-60 ml Liq. softener |
| H66810140311 | SC Lab Kit, 2-50g Pwd, 1-60 ml Liq. hardener, 1-60 ml Liq. softener |
| H66810140251 | 2 oz Sealer |
| H66810140241 | 1/2 oz Sealer |
| H66810140231 | Acrylic Pink 1 lb Pwd |
| H66810140221 | Acrylic Clear 1 lb Pwd |
| H66810140211 | Acrylic Pink 2 oz Pwd |
| H66810140201 | Acrylic Clear 2 oz Pwd |
| H66810140191 | Acrylic HC Pre-Mixed Liquid 1 Qt |
| H66810140181 | Acrylic SC Pre-Mixed Liquid 1 Qt |
| H66810140171 | Acrylic HC Hardener Liquid 1 Qt |
| H66810140161 | Acrylic SC Hardener Liquid 1 Qt |
| H66810140151 | Reline Softening Liquid 1 Qt |
| H66810140141 | Acrylic HC Pre-Mixed Liquid 60 ml |
| H66810140131 | Acrylic SC Pre-Mixed Liquid 60 ml |
| H66810140121 | Acrylic HC Hardener Liquid, 60 ml |
| H66810140111 | Acrylic SC Hardener Liquid 60 ml |
| H66810140101 | Acrylic Softening Liquid, 60 ml |
| H66810140261 | Acrylic Pink 25 lb Pwd bucket |
Trademark Results [Versacryl]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERSACRYL 85625476 4288317 Live/Registered |
Innovative Plastics Technologies LLC 2012-05-15 |
 VERSACRYL 85204168 not registered Dead/Abandoned |
Innovative Plastics Technology, LLC 2010-12-22 |
 VERSACRYL 76587480 2964801 Live/Registered |
Mycone Dental Supply Co., Inc. 2004-04-19 |
 VERSACRYL 73719172 1598001 Dead/Cancelled |
S. C. JOHNSON & SON, INC. 1988-03-28 |
 VERSACRYL 73707969 not registered Dead/Abandoned |
NATIONAL STARCH AND CHEMICAL CORPORATION 1988-01-27 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.