BruxZir 70-1185-BXP0584
GUDID D745701185BXP05840
BruxZir Shaded 16 PLUS GL Bridge Block - D2
James R. Glidewell, Dental Ceramics, Inc.
Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic Dental appliance fabrication material, ceramic| Primary Device ID | D745701185BXP05840 |
| NIH Device Record Key | a4c92d40-0a65-4ac0-8c93-d4a040dfcc63 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BruxZir |
| Version Model Number | 70-1185-BXP0584 |
| Catalog Number | 70-1185-BXP0584 |
| Company DUNS | 021228671 |
| Company Name | James R. Glidewell, Dental Ceramics, Inc. |
| Device Count | 20 |
| 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 | 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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| 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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| 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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| 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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| 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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| 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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| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| Phone | +1(800)854-7256 |
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| Phone | +1(800)854-7256 |
| xx@xx.xx | |
| 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 | D745701185BXP05840 [Unit of Use] |
| HIBCC | D745701185BXP05841 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K130924
FDA Product Code
| EIH | POWDER, PORCELAIN |
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 | 2023-06-20 |
| Device Publish Date | 2023-06-12 |
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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