AccessGUDID - DEVICE: ACTEON (03609820873367)

GUDID

Device Identifier (DI) Information

Brand Name: ACTEON
Version or Model: SL INTRALIFT KIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: F87336
Company Name: SATELEC

Primary DI Number: 03609820873367
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 381582196 *Terms of Use

Device Description: The hydrodynamic sinus lift technique by the crestal approach. The diamond-coated tips, of increasing diameters (from 1.35mm to 2.80mm), are designed to drill and widen gradually the access canal to the Schneider membrane. The sterile spray cools down the tips to avoid any rise in temperature, which could lead to tissue damage. The membrane elevation is achieved using the TKW5 by means of microcavitation.

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:	Yes
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?
47015	Dental ultrasonic surgical system handpiece tip	A removable endpiece intended to be attached to a dental ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to mechanically fragment and cut bone during dental surgery. The device is available in a variety of forms (e.g., flat serrated blade, ball head, nail head, or probe-like) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). It is used for implant site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty, and osteotomy. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DZI	Drill, Bone, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091252	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: add10d56-936c-4f62-931a-4084cfaa466f
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016