MAXSO

GUDID 00837699000208

X200-M/K.Kavo® Connection,Fiber-optic, Triple Water Spray

Beyes Dental Canada Inc

Pneumatic dental handpiece coupler

• Primary Device ID: 00837699000208
• NIH Device Record Key: 0c50d1fe-776f-4c54-a953-bf5930c82b6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MAXSO
• Version Model Number: HP2060
• Company DUNS: 244261462
• Company Name: Beyes Dental Canada 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: false
• Serial Number: true
• Manufacturing Date: false
• 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
GS1	00837699000208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101551

FDA Product Code

• EFB: Handpiece, Air-Powered, Dental

Sterilization

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

[00837699000208]

Moist Heat or Steam Sterilization

[00837699000208]

Moist Heat or Steam Sterilization

[00837699000208]

Moist Heat or Steam Sterilization

[00837699000208]

Moist Heat or Steam Sterilization

[00837699000208]

Moist Heat or Steam Sterilization

[00837699000208]

Moist Heat or Steam Sterilization

[00837699000208]

Moist Heat or Steam Sterilization

[00837699000208]

Moist Heat or Steam Sterilization

[00837699000208]

Moist Heat or Steam Sterilization

[00837699000208]

Moist Heat or Steam Sterilization

[00837699000208]

Moist Heat or Steam Sterilization

[00837699000208]

Moist Heat or Steam Sterilization

[00837699000208]

Moist Heat or Steam Sterilization

[00837699000208]

Moist Heat or Steam Sterilization

[00837699000208]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-13
• Device Publish Date: 2022-10-05

On-Brand Devices [MAXSO]

• 00837699001083: X200-45/N,45 Degree Head, Fiber-optic, Triple Water Jet
• 00837699001076: M200-M/N,Non-optic, Triple Water Spray
• 00837699001069: M200-M/PD,Non-optic, Triple Water Spray
• 00837699001052: M200-M/B2,Non-optic, Triple Water Spray
• 00837699001045: M200-45/B2,45°Head, Rear Exhaust, Stream Water, Non-optic
• 00837699001038: M200E-M/B2, Non-optic, Single Water Spray
• 00837699000260: M200E-M/M4,Non-optic, Single Water Spray
• 00837699000253: X200X-M/N,NSK Backend, Quattro Spray, IS Technology, Fiber Optic (NEW)
• 00837699000246: X200-M/N,Fiber-optic, Triple Water Spray
• 00837699000215: X200X-M/K,KaVo Backend, Quattro Spray, IS Technology, Fiber Optic (NEW)
• 00837699000208: X200-M/K.Kavo® Connection,Fiber-optic, Triple Water Spray
• 00837699000192: M200-M/QD, Beyes QD Backend, Triple Spray, Non-Optic
• 00837699000185: M200-45/M4,Midwest® 4 Hole,45°Head, Rear Exhaust, Triple Spray, Non-optic
• 00837699000178: M200-M/M4,Midwest® 4 Hole,Non-optic, Triple Water Spray
• 00837699000956: Low Speed Kit M4 NS (M20A-NS/M4 + CS1-CH04 + S20A)
• 00837699000819: S20A-NS,Straight Nose Cone, No Spray, 1:1
• 00837699000802: S20A-IS/E6,Straight Nose Cone, 1:1Internal Spray, Fiber-Optic
• 00837699000796: S20A-IS,Straight Nose Cone, 1:1 Internal Spray, Non-Optic
• 00837699000758: M29L-MH01,Contra Angle, Internal Spray, Fiber-Optic, Push Button, CA Burs
• 00837699000741: M29-MH01,Contra Angle,Internal Spray, Non-Optic, Push Button, CA Burs
• 00837699000734: MH01,Head, Push Button, CA Burs
• 00837699000727: X99L,Fiber Optic, 4 ports Spray, 1:5 Increaser, FG Bur
• 00837699000710: X92,Contra Angle, 20:1 Implantology, Non-Optic, Push Button, CA Burs
• 00837699000703: CS1-CH09,Contra Angle, Screw-On, 1:1
• 00837699000697: CS1-CH08, Contra Angle, Snap-On, 1:1
• 00837699000680: CS1-CH04,Contra Angle, Latch Type, CA Burs, 1:1
• 00837699000673: CS1-CH02,Contra Angle, Push Botton, CA Burs, 1:1
• 00837699000666: CH09,Head, Screw-On
• 00837699000659: CH08, Head, Snap-On
• 00837699000642: CH04,Head, Latch Type, CA Burs
• 00837699000635: CH02,Head, Push Botton, CA Burs
• 00837699000628: CS4, Sheath, 4:1 Reduction
• 00837699000611: CS1,Sheath, 1:1 Direct Drive
• 00837699000604: EP12-NS,Hygiene Handpiece for DPA (Disposable Prophy Angle), 4:1
• 00837699000598: E600 Control Unit, Portable System Control Unit, Digital Speed Display, F/R
• 00837699000581: E600 Built-In Panel
• 00837699000574: E600 MC Motor, Brushless, Autoclavable, Exclude Cord
• 00837699000567: E600 Cord, For Micromotor
• 00837699000550: E600 Built-In Control Unit, Digital Speed Display, F/R
• 00837699000543: E600 Built-In Cord, For Micromotor
• 00837699000536: M600B (Built-In),Control Unit, Display Unit, Autoclavable Brushless Motor, Cord for Micromotor
• 00837699000529: M600P (Portable),Portable System Control Unit with Digital Speed Display, Autoclavable Brushless
• 00837699000512: M20A-NS/M4,Air Motor, No Spray, 20k
• 00837699000505: M20A-IS/M4,Air Motor, M4 Backend, Internal Spray, Non-Optic, 20k
• 00837699000017: Maxso E800P, Portable Electric Handpiece System
• 00990010301207: Maxso E800P, Portable Electric Handpiece System
• 00990010302389: Low Speed Kit B2 (M20A-ES/B2 + CS1-CH04 + S20A)
• 00990010302334: Maxso E800B, Built - In ,Control Unit with Digital Speed Display, Autoclavable Brushless Motor,
• 00990010302310: M20A-ES/M4, Air Motor
• 00990010302280: X97,Dental Low Speed Handpiece-Contra Angle(Handpiece)