Britedent

GUDID D974BSI012

Disposable Impression Trays # 1 Large Upper

Bright Supply, Inc.

Dental impression tray, single-use

• Primary Device ID: D974BSI012
• NIH Device Record Key: 308c1caa-fc5c-4d13-8b71-5bde87cab4aa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Britedent
• Version Model Number: BSI-01
• Company DUNS: 124117012
• Company Name: Bright Supply, Inc.
• Device Count: 12
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D974BSI010 [Unit of Use]
HIBCC	D974BSI011 [Primary]
HIBCC	D974BSI012 [Package]; Contains: D974BSI011; Package: Bag [10 Units]; In Commercial Distribution

FDA Product Code

• EBH: Material, Impression Tray, Resin

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: 2021-03-09
• Device Publish Date: 2021-03-01

On-Brand Devices [Britedent]

• D974BSIS12CC2: Utility syringe curved 12cc
• D974BSI99012: Vented Evacuation Tips White Color
• D974BSI90020: Saliva Ejector White with White Tip
• D974BSI90010: Saliva Ejector Clear with Blue Tip
• D974BSI70050: Dental Impression Bite Tray Sideless (White)
• D974BSI7004G0: Dental Impression Bite Tray Posterior Short (Green)
• D974BSI70032: Dental Impression Bite Tray Quadrant (Yellow)
• D974BSI70022: Dental Impression Bite Tray Anterior (Purple)
• D974BSI70012: Dental Impression Bite Tray Full Arch (Pink)
• D974BSI60022: Air-Water syringe tips (Rainbow)
• D974BSI40042: Gauze Non Woven Sponges 4 x 4 Inch.
• D974BSI30002: Cotton Roll #2 Medium Non-Sterile (1.5" x 3/8")
• D974BSI28300: 5oz Disposable Plastic Dental Cup Lavender
• D974BSI28250: 5oz Disposable Plastic Dental Cup White
• D974BSI28150: 5oz Disposable Plastic Dental Cup Pink
• D974BSI28100: 5oz Disposable Plastic Dental Cup Blue
• D974BSI24271: Disposable Dental Bib White 13" x 18" (500 bibs)
• D974BSI24261: Disposable Dental Bib Pink 13" x 18" (500 bibs)
• D974BSI24241: Disposable Dental Bib Green 13" x 18" (500 bibs)
• D974BSI24211: Disposable Dental Bib Blue 13" x 18" (500 bibs)
• D974BSI20022: Gauze Non Woven Sponges 2 x 2 Inch.
• D974BSI10232: Prebent Dispensing Tips Blue 23 Gauge
• D974BSI10032: Surgical Aspirator Tips Green Large Vented 1/4" Diam
• D974BSI10012: Surgical Aspirator Tips Blue Small Vented 1/16" Diam
• D974BSI01022: Barrier Film Clear
• D974BSI01011: Barrier Film Blue
• D974BSI90230: (2 1/4" x 9'") Sterilization Pouches
• D974BSI65352: ( 3 1/2" x 5 1/4") Sterilization Pouches
• D974BSI19122: (12" X 19") Sterilization Pouches
• D974BSI16102: (10" x 16") Sterilization Pouches
• D974BSI14752: (7 1/2" x 14") Sterilization Pouches
• D974BSI10352: (3 1/2" X 10") Sterilization Pouches
• D974BSI10270: (2 3/4" x 9") Sterilization Pouches
• D974BSI6004C2: Air-Water syringe tips (White-White)
• D974BSI60032: Air-Water syringe tips (Clear)
• D974BSI072: Disposable Impression Trays # 7 Upper Left/ Low Right
• D974BSI062: Disposable Impression Trays # 6 Small Lower
• D974BSI052: Disposable Impression Trays # 5 Small Upper
• D974BSI042: Disposable Impression Trays # 4 Medium Lower
• D974BSI032: Disposable Impression Trays # 3 Medium Upper
• D974BSI022: Disposable Impression Trays # 2 Large Lower
• D974BSI012: Disposable Impression Trays # 1 Large Upper
• D974BS102: Disposable Impression Trays # 10 Anterior Lower
• D974BSI25001: Blue Paper Tray Cover 8.5" x 12.25"
• D974BSI29140: X-Ray Sensor Sleeves 8" x 1-5/8"
• D974BSI29090: Tray Sleeves 10-1/2" x 14"
• D974BSI29010: Full Chair Sleeves 29" x 80"
• D974BSI11522: (5 1/4" x 10") Sterilization Pouches
• D974BSI30030: Gauze Non Woven Sponges 3 x 3 Inch.
• D974BSI29182: Syringe Sleeves with Pre-Cut Opening 2-1/2" x 10"