KOMET Dental Diamond Instruments 868B.314.020

GUDID E226100058448

Gebr. Brasseler GmbH & Co. KG

Diamond dental bur, reusable

• Primary Device ID: E226100058448
• NIH Device Record Key: f5e156cb-6b26-4991-bc93-47e7c1564127
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KOMET Dental Diamond Instruments
• Version Model Number: 868B.314.020.AU
• Catalog Number: 868B.314.020
• Company DUNS: 317409001
• Company Name: Gebr. Brasseler GmbH & Co. KG
• Device Count: 5
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E226100058441 [Primary]
HIBCC	E226100058448 [Unit of Use]

FDA Product Code

• DZP: INSTRUMENT, DIAMOND, DENTAL

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[E226100058448]

Moist Heat or Steam Sterilization

[E226100058448]

Moist Heat or Steam Sterilization

[E226100058448]

Moist Heat or Steam Sterilization

[E226100058448]

Moist Heat or Steam Sterilization

[E226100058448]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-09
• Device Publish Date: 2023-02-01

On-Brand Devices [KOMET Dental Diamond Instruments]

• E527042995DA2: E392F.314.016.DA
• E226100138998: KP6863.314.014.A2
• E226100138968: KP6863.314.016.A2
• E226100138938: KP6878K.314.021.A2
• E226100138868: KP6379E.314.029.A2
• E226100138838: KP6368.314.016.A2
• E226100130798: 4COMP.314.012.A2
• E226100130768: KP6856XL.314.021.A2
• E226100125818: BCD5.314.047.A2
• E226100125808: BCD4S.314.049.A2
• E226100125798: BCD4M.314.049.A2
• E226100105548: BCD4L.314.049.A2
• E226100105538: BCD3S.314.039.A2
• E226100105528: BCD3M.314.039.A2
• E226100105518: BCD3L.314.039.A2
• E226100105508: BCD2.314.031.A2
• E226100105498: BCD1.314.039.A2
• E226100085278: 8972.314.020.A2
• E226100062908: KP6370.314.035.A2
• E226100062608: KP6879.314.012.A2
• E226100062508: KP6881.314.016.A2
• E226100058448: 868B.314.020.AU
• E226100053551: 6881.314.018.A1
• E226100053521: 881.314.016.A1
• E226100052418: 6888.314.012.AL
• E226100041428: ZR379.314.023.A2
• E226100041288: ZR8379.314.023.A2
• E226100022952: 5909SU.314.040.GS
• E226100022932: 8392SU.314.016.GS
• E226100022922: 8274SU.314.016.GS
• E226100022912: 8811SU.314.037.GS
• E226100022902: 8811SU.314.033.GS
• E226100022892: 6811SU.314.037.GS
• E226100022882: 6811SU.314.033.GS
• E226100022872: 5811SU.314.037.GS
• E226100022862: 5811SU.314.033.GS
• E226100022852: 8379SU.314.023.GS
• E226100022842: 8379SU.314.018.GS
• E226100022832: 379SU.314.023.GS
• E226100022822: 379SU.314.018.GS
• E226100022812: 6379SU.314.023.GS
• E226100022802: 6379SU.314.018.GS
• E226100022792: 5379SU.314.023.GS
• E226100022782: 5379SU.314.018.GS
• E226100022772: 8368SU.314.023.GS
• E226100022762: 8368SU.314.016.GS
• E226100022542: 368SU.314.023.GS
• E226100022532: 368SU.314.016.GS
• E226100022522: 6368SU.314.023.GS
• E226100022512: 6368SU.314.016.GS