Alpen

GUDID D661XU835C0101

FLAT END TPR 835 010 C

COLTENE/WHALEDENT INC

Carbide dental bur, reusable

• Primary Device ID: D661XU835C0101
• NIH Device Record Key: 20ce6e5d-26ce-40a0-b05a-a71ca6395604
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alpen
• Version Model Number: XU835C010
• Company DUNS: 622185718
• Company Name: COLTENE/WHALEDENT INC
• Device Count: 100
• 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: true
• 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	D661XU835C0100 [Unit of Use]
HIBCC	D661XU835C0101 [Primary]

FDA Product Code

• EJL: Bur, Dental

Sterilization

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

[D661XU835C0101]

Radiation Sterilization;Moist Heat or Steam Sterilization

[D661XU835C0101]

Radiation Sterilization;Moist Heat or Steam Sterilization

[D661XU835C0101]

Radiation Sterilization;Moist Heat or Steam Sterilization

[D661XU835C0101]

Radiation Sterilization;Moist Heat or Steam Sterilization

[D661XU835C0101]

Radiation Sterilization;Moist Heat or Steam Sterilization

[D661XU835C0101]

Radiation Sterilization;Moist Heat or Steam Sterilization

[D661XU835C0101]

Radiation Sterilization;Moist Heat or Steam Sterilization

[D661XU835C0101]

Radiation Sterilization;Moist Heat or Steam Sterilization

[D661XU835C0101]

Radiation Sterilization;Moist Heat or Steam Sterilization

[D661XU835C0101]

Radiation Sterilization;Moist Heat or Steam Sterilization

[D661XU835C0101]

Radiation Sterilization;Moist Heat or Steam Sterilization

[D661XU835C0101]

Radiation Sterilization;Moist Heat or Steam Sterilization

[D661XU835C0101]

Radiation Sterilization;Moist Heat or Steam Sterilization

[D661XU835C0101]

Radiation Sterilization;Moist Heat or Steam Sterilization

[D661XU835C0101]

Radiation Sterilization;Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-03-23
• Device Publish Date: 2019-02-12

On-Brand Devices [Alpen]

• D66600194081: LAM856-314-012-8-ML - RE TAPER
• D661XU909C0351: RND WHEEL 909 035 C
• D661XU881SC0141: U SU DMND RND CLDR 881 014 SC
• D661XU881SC0121: U SU DMND RND CLDR 881 012 SC
• D661XU881F0101: U SU DMND RND CLDR 881 010 F
• D661XU881C0101: U SU DMND RND CLDR 881 010 C
• D661XU878KSC0181: U SU DMND CURETTAGE 878K 18 C
• D661XU878KC0161: U SU DMND CURETTAGE 878K 16C
• D661XU878KC0141: U SU DMD CURETTAGE 878K 14 C
• D661XU878KC0121: U SU DMD MODBVLDCYLDR878K 12 C
• D661XU878F0121: U SU DMND CLDR 878 012 F
• D661XU878C0141: U SU DMND BLVD CLDR 878 014 C
• D661XU878C0121: U SU DMND BLVD CLDR 878 012 C
• D661XU862C0121: U SU DMD FLAME 862 12 C
• D661XU859C0141: U SU DMND FLAME 859 014 C
• D661XU856SC0211: U SU RND END TPR 856 21 SC
• D661XU856SC0181: U SU DMD RND END TPR 856 18 SC
• D661XU856SC0141: RND END TPR 856 014 C
• D661XU856LSC0181: U SU DMD L RND ENDTPR856 18 SC
• D661XU856F0181: RND END TPR 856 018 F
• D661XU8568SC0161: U SU DMD RND END TPR 856 16 SC
• D661XU8568F0161: RND END TPR 8568 016 F
• D661XU848SC0161: U SU DMD FLT END TPR 848 16 SC
• D661XU835C0101: FLAT END TPR 835 010 C
• D661XU811SC0331: OCCLUSAL 811 033 SC
• D661XU379SC0231: UNVRSTY SU DMND EGG 379 023 C
• D661XU379F0231: U SU DMND EGG 379 023 F
• D661XU10839M0121: END CUTTING 10839 012 M
• D661X909C0421: ALPEN X1 WHEEL, COARSE
• D661X909C0351: ALPEN X1 WHEEL, COARSE
• D661X889F0091: ALPEN X1 FLAME, FINE
• D661X886M0121: BEVELED CYLINDER, MEDIUM
• D661X886C0121: BEVELED CYLINDER, COARSE
• D661X885M0121: BEVELED CYLINDER, MEDIUM
• D661X885F0121: BEVELED CYLINDER, FINE
• D661X885C0121: BEVELED CYLINDER, COARSE
• D661X881SC0141: ROUND END CYLINDER SC
• D661X881SC0121: ROUND END CYLINDER SC
• D661X881F0091: ROUND END CYLINDER FINE
• D661X881C0091: ROUND END CYLINDER COARSE
• D661X879KSC0181: POINTED TAPER SC
• D661X879KM0181: POINTED TAPER MEDIUM
• D661X879KM0141: POINTED TAPER MEDIUM
• D661X879KM0121: POINTED TAPER MEDIUM
• D661X879KC0141: ALPEN X1 POINTED TAPER,COARSE
• D661X879KC0121: ALPEN X1 POINTED TAPER,COARSE
• D661X878KSC0181: POINTED TAPER SC
• D661X878KM0161: POINTED TAPER MEDIUM
• D661X878KM0141: POINTED TAPER MEDIUM
• D661X878KM0121: POINTED TAPER MEDIUM