BruxZir 70-1014-BRX0019
GUDID D745701014BRX00190
BruxZir® Tapered Bur- 021mm (3-pack)
James R. Glidewell, Dental Ceramics, Inc.
Diamond dental bur, reusable| Primary Device ID | D745701014BRX00190 |
| NIH Device Record Key | 3746389e-a5f4-476a-bd51-4c771c1dfb47 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BruxZir |
| Version Model Number | 70-1014-BRX0019 |
| Catalog Number | 70-1014-BRX0019 |
| Company DUNS | 021228671 |
| Company Name | James R. Glidewell, Dental Ceramics, Inc. |
| Device Count | 3 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | 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(800)854-7256 |
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| Phone | +1(800)854-7256 |
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| Phone | +1(800)854-7256 |
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| Phone | +1(800)854-7256 |
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Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D745701014BRX00190 [Unit of Use] |
| HIBCC | D745701014BRX00191 [Primary] |
FDA Product Code
| EJL | BUR, DENTAL |
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 | 2023-04-18 |
| Device Publish Date | 2023-04-10 |
On-Brand Devices [BruxZir]
| D74544000680 | BruxZir Spray Glaze Powder |
| D745701014BRX00220 | BruxZir® Brown Polishing Disk (3-pack) Refill |
| D745701014BRX00210 | BruxZir® Blue Polishing Disc (3-pack) Refill |
| D745701014BRX00190 | BruxZir® Tapered Bur- 021mm (3-pack) |
| D745701014BRX00180 | BruxZir® Round Bur – 018mm (3-pack) |
| D745701014BRX00170 | BruxZir® Green Polishing Cup (3-pack) |
| D745701014BRX00160 | BruxZir® Diamond football Bur (3-pack) |
| D745701014BRX00140 | BZ Green Brown White Polishing Cup (3-pack) |
| D745701014BRX00130 | BZ Round Football Tapered Burs (3-pack) |
| D745701014BRX00120 | BruxZir® White Polishing Cup (3-pack) |
| D745701014BRX00110 | BruxZir® Brown Polishing Cup (3-pack) |
| D745701014BRX00070 | BruxZir® Adjustment and Polishing Kit |
| D7451014BRX00220 | BruxZir™ Brown Polishing Disc, 3/Pk |
| D7451014BRX00210 | BruxZir™ Blue Polishing Disc, 3/Pk |
| D7451014BRX00190 | BruxZir™ Tapered Bur (021 mm), 3/Pk |
| D7451014BRX00180 | BruxZir™ Round Bur (018 mm), 3/Pk |
| D7451014BRX00170 | BruxZir™ Green Polishing Cup, 3/Pk |
| D7451014BRX00160 | BruxZir™ Diamond Football Bur, 3/Pk |
| D7451014BRX00140 | BruxZir™ Polishing Cup set, 3/Pk |
| D7451014BRX00130 | BruxZir™ Bur Set 3/Pk |
| D7451014BRX00120 | BruxZir™ White Polishing Cup, 3/Pk |
| D7451014BRX00110 | BruxZir™ Brown Polishing Cup, 3/Pk |
| D7451014BRX00070 | BruxZir™ Adjustment & Polishing Kit |
| D745701186BXP03100 | BruxZir Shaded 16 PLUS GL Bridge Block - B1 |
| D745701186BXP03060 | BruxZir Shaded 16 PLUS GL Bridge Block - A2 |
| D745701185BXP05890 | BruxZir Shaded 16 PLUS GL Bridge Block - White |
| D745701185BXP05880 | BruxZir Shaded 16 PLUS GL Bridge Block - BL3 |
| D745701185BXP05870 | BruxZir Shaded 16 PLUS GL Bridge Block - BL1 |
| D745701185BXP05860 | BruxZir Shaded 16 PLUS GL Bridge Block - D4 |
| D745701185BXP05850 | BruxZir Shaded 16 PLUS GL Bridge Block - D3 |
| D745701185BXP05840 | BruxZir Shaded 16 PLUS GL Bridge Block - D2 |
| D745701185BXP05830 | BruxZir Shaded 16 PLUS GL Bridge Block - C4 |
| D745701185BXP05820 | BruxZir Shaded 16 PLUS GL Bridge Block - C3 |
| D745701185BXP05810 | BruxZir Shaded 16 PLUS GL Bridge Block - C2 |
| D745701185BXP05800 | BruxZir Shaded 16 PLUS GL Bridge Block - C1 |
| D745701185BXP05790 | BruxZir Shaded 16 PLUS GL Bridge Block - B4 |
| D745701185BXP05780 | BruxZir Shaded 16 PLUS GL Bridge Block - B3 |
| D745701185BXP05770 | BruxZir Shaded 16 PLUS GL Bridge Block - B2 |
| D745701185BXP05760 | BruxZir Shaded 16 PLUS GL Bridge Block - B1 |
| D745701185BXP05750 | BruxZir Shaded 16 PLUS GL Bridge Block - A4 |
| D745701185BXP05740 | BruxZir Shaded 16 PLUS GL Bridge Block - A3.5 |
| D745701185BXP05730 | BruxZir Shaded 16 PLUS GL Bridge Block - A3 |
| D745701185BXP05720 | BruxZir Shaded 16 PLUS GL Bridge Block - A2 |
| D745701185BXP05710 | BruxZir Shaded 16 PLUS GL Bridge Block - A1 |
| D74570BZDC0 | BruxZir™ Dual Cure Resin Cement |
| D7457025AM0 | 25 Automix Applicator Tips |
Trademark Results [BruxZir]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BRUXZIR 85332886 4714556 Live/Registered |
James R. Glidewell Dental Ceramics Inc. 2011-05-27 |
 BRUXZIR 77761757 3739663 Live/Registered |
James R. Glidewell, Dental Ceramic, Inc. 2009-06-17 |
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