AccessGUDID - DEVICE: SURGmatic S15 L Pro (EKAV101440000)

GUDID

Device Identifier (DI) Information

Brand Name: SURGmatic S15 L Pro
Version or Model: 1.014.4000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S15 L Pro
Company Name: KaVo Dental GmbH

Primary DI Number: EKAV101440000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 333710619 *Terms of Use

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 fillings The SURGmatic S15 L Pro is for use by a trained professional in the field of general dentistry and / or oral surgery.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38347	Dental power tool system handpiece, line-powered	A 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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EGS	Handpiece, contra- and right-angle attachment, dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K213139	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between -29 and 50 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5281cc50-5b1c-4974-97d5-5c592fac9518
Public Version Date: March 21, 2022
Public Version Number: 1
DI Record Publish Date: March 11, 2022