REF
Product Designation
Pretreatment
Manual
Cleaning/
Disinfection
Mechanical
Cleaning/
Disinfection
(validated)
Sterilization
Recommended
Classification accor-
ding to RKI/BfArM/
Kriniko guideline
Multiple use
01170010
JMA-Optic Face Bow
not permissible
Immersion
not permissible
Wipe disinfection
permissible
not permissible
non-critical
permissible
01470000
UK-Sensor OJM-UK1
Lower Jaw Sensor
not permissible
Immersion
not permissible
Wipe disinfection
permissible
not permissible non-critical
permissible
01870010
Induktive Charger
JMA-Optic
not permissible
Immersion
not permissible
Wipe disinfection
not permissible not permissible no contact
to the patient
permissible
01970211
C-Bow JMA-Optic
permissible
Immersion
not permissible
Wipe disinfection
permissible
Standard
procedure
non-critical
permissible
01910025
T-Pointer JMA-Optic
permissible
not recommended permissible
Standard
procedure
semi-critical A
permissible
01960160
Porus Buttons
permissible
not recommended permissible
Standard proce-
dure
semi-critical A
permissible
01960250
Para-Occlusal
Attachment
with Lip Arch
permissible
not recommended permissible
Standard
procedure
semi-critical B
5x permissible
01960255
Para-Occlusal
Attachment with
Support Surface
permissible
not recommended permissible
Standard
procedure
semi-critical B
5x permissible
01960140
Retainer for Face Bow
not permissible
permissible
permissible
not permissible non-critical
permissible
11502501
Bearing Cushion
not permissible
permissible
permissible
not permissible non-critical
permissible
11502503
Nose Cushion
not permissible
permissible
permissible
not permissible non-critical
permissible
11502509
Overhead Band
not permissible
permissible
permissible
not permissible non-critical
permissible
01960400
Bite Fork Adapter
not permissible
permissible
not permissible not permissible non-critical
permissible
01960410
Bite Fork Adapter
Type LP
not permissible
permissible
not permissible not permissible non-critical
permissible
01960270
Occlusal Attachment
not permissible
not recommended permissible
Standard
procedure
semi-critical B
not permissible
01960271
Occlussal Adapter
permissible
not recommended permissible
Standard
procedure
semi-critical B
5x permissible
01960320
Bite Fork Type SD
permissible
not recommended permissible
Standard
procedure
semi-critical B
3x permissible
01960315
Coupling Spoon
Intraoral LP
permissible
not recommended permissible
Standard
procedure
semi-critical B
3x permissible
01960340
Bite Fork Type PS-1
permissible
not recommended permissible
Standard
procedure
semi-critical B
3x permissible
01970110
T-Pointer JMA-Optic
permissible
not recommended permissible
Standard
procedure
semi-critical A
permissible
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JMA-Optic
8.8. Summary table
Non-critical products:
Medical devices that come into contact with intact skin only.
Semi-critical devices:
Medical devices that come into contact with mucous membrane or pathologically altered skin.