AccessGUDID - DEVICE: Planmeca Compact (06430035420438)

GUDID

Device Identifier (DI) Information

Brand Name: Planmeca Compact
Version or Model: i
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 10031950, 10031951, 10031952, 10031953, 10039745, 10031954, 10031955
Company Name: Planmeca Oy

Primary DI Number: 06430035420438
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 368788568 *Terms of Use

Device Description: Planmeca Compact i is a dental operative unit including a dental patient chair. The unit is equipped with a digital control system and a user interface which is either a touch panel or a traditional keyboard. The instrument console includes five instrument locations, with easy instrument change.

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):	No
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?
34991	Dental delivery system	A stationary, mains electricity (AC-powered) device assembly designed to provide dental staff with the necessary utilities/amenities to deliver dental treatment to a patient. The utilities/amenities are typically compressed air, water, suction, electricity, table top or bracket table surfaces, cuspidor, gas, and sometimes the dental light. This is a fixed-position system (i.e., not mobile) which incorporates an instrument unit for dental instrument provision. The patient examination/treatment chair is typically integrated as part of this system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIA	Unit, Operative Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K961420	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

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: e9da7e40-ba98-42a0-8dfa-244bbb4d5213
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: May 05, 2017