FDA.reportPublic FDA data

SURGmatic S15 L Pro

Primary DI
EKAV101440000
Brand
SURGmatic S15 L Pro
Company
KaVo Dental GmbH
Model
1.014.4000
Catalog number
S15 L Pro
Device description
The SURGmatic S15 L Pro handpiece is intended for:• Oral, jaw and facial surgery• Tooth extraction procedures• Root resection• Osteotomy• Removal of carious material• Tooth, cavity and crown preparations• Processing of fillingsThe SURGmatic S15 L Pro is for use by a trained professional in the field of generaldentistry and / or oral surgery.
Published
2022-03-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EGSHandpiece, contra- and right-angle attachment, dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGSHandpiece, Contra- And Right-Angle Attachment, DentalDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213139000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213139000SURGmatic S15 L ProKavo Dental GmbH2021-12-21EGS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EKAV101440000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental power tool system handpiece, line-poweredA hand-held, mains electricity (AC-powered) dental device that includes a chuck or collet for attaching a dental endpiece (e.g., drill bit, bur, reamer, saw blade, polishing disk) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. It is powered by a low-voltage electric micro-motor (e.g., 24 volt) that is an integral part of the device; the endpiece(s) are not included. It is typically connected through the dental delivery system or a freestanding independent control unit. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-29 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+18475506800customerservice@kavo.com

Regulatory Flags#

DUNS number
333710619
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EKAV057405000DIAGNOdent 20950.574.050020952016-09-26
EKAV100059540RONDOflex powder 50m (75g)1.000.5954NA2016-09-26
EKAV100059550RONDOflex powder 27m (75g)1.000.5955NA2016-09-26
EKAV100059560RONDOflex powder 50m (1000g)1.000.5956NA2016-09-26
EKAV100059570RONDOflex powder 27m (1000g)1.000.5957NA2016-09-26
EKAV100720000SonicFill Handpiece 349201.007.2000349202016-09-26
EKAV100620270SONICflex implant set A1.006.20271.006.20272025-01-31
EKAV100863840SONICflex prep crown round no. 97 A1.008.63841.008.63842025-01-31
EKAV100863860SONICflex prep crown plain no. 98 A1.008.63861.008.63862025-01-31
EKAV101537000DIAGNOcam Vision Full HD1.015.37001.015.37002024-12-03
EKAV100835000EXPERTsurg LUX1.008.35001.008.35002016-09-26
EKAV100987570Tube Set S6001.009.8757S6002016-09-26
EKAV100880000INTRA LUX S600 LED1.008.80001.008.80002016-09-26
EKAV100910100SURGmatic S11 L1.009.10101.009.10102016-09-26
EKAV101375400SURGmatic S201 L Pro1.013.75401.013.75402020-01-24
EKAV101375410SURGmatic S201 XL Pro1.013.75411.013.75412020-01-24
EKAV101112130DIAGNOcam Vision Full HD1.011.12131.011.12132024-02-01
EKAV101315000DIAGNOcam Vision Full HD1.013.15001.013.15002024-02-01
EKAV101402800MASTERmatic LUX M45 L1.014.02801.014.02802024-02-01
EKAV100071050SONICflex cari-ex 0.8 No. 421.000.7105cari ex 0 8 No 422016-09-26

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Primary DI, Brand, Company table
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D77142133771Dental CityICP, INC.EGS2026-05-27
10304040196974Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
10304040196981Henry ScheinHENRY SCHEIN, INC.EGS2026-05-14
08809260470279TRAUSSaeshin Precision Co., Ltd.EGS2026-03-31
10686864060946MEDICOM DENTICARE AMD Medicom IncEGS2026-02-25
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10686864061141MEDICOM DENTICAREAMD Medicom IncEGS2025-03-18
10686864060915MEDICOM DENTICARE SWIVEL DPA, SOFT CUPAMD Medicom IncEGS2024-09-27
10686864060922MEDICOM DENTICARE SWIVEL DPA, FIRM CUPAMD Medicom IncEGS2024-09-27
10686864060939MEDICOM DENTICARE SWIVEL DPA, TAPERED BRUSHAMD Medicom IncEGS2024-09-27
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