BruxZir 70-BZDC

GUDID D74570BZDC0

BruxZir™ Dual Cure Resin Cement

James R. Glidewell, Dental Ceramics, Inc.

Dental composite resin

• Primary Device ID: D74570BZDC0
• NIH Device Record Key: 5cc0e946-cef6-4624-ba4e-1b8a22cfd03c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BruxZir
• Version Model Number: 70-BZDC
• Catalog Number: 70-BZDC
• Company DUNS: 021228671
• Company Name: James R. Glidewell, Dental Ceramics, Inc.
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D74570BZDC0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132393

FDA Product Code

• EMA: CEMENT, 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: 2023-08-18
• Device Publish Date: 2023-08-10

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