FIXED PROS - Medical Device Regulations

Question 1

define a custom made medical device.

Answer 1

a device manufactured specifically with a written prescription from a registered medical practitioner or other authorised person

intended for the sole use of a particular person

but not including a mass-produced product which needs to be adapted

AKA made for one person via prescription

Question 2

give examples of medical devices.

Answer 2

dentures
partial dentures
bridges
crowns
dental implants
inlays/onlays

Question 3

what are NOT classified as medical devices?

Answer 3

• fillings
• temp fillings
• chair side temp crowns
• splints for teeth after trauma

Question 4

2009, how many adults wear dentures?

Answer 4

1/5

Question 5

2009, how many dentate adults have crowns, bridges and implants?

Answer 5

crowns - 37%
bridge - 7%
implants - 1%

Question 6

what is the need for custom made dental device?

Answer 6

numbers of partially dentate adults are increasing

Question 7

what can dental nurses manufacture with extra training?

Answer 7

they can pour, cast and trim STUDY MODELS

Question 8

what can dental nurses manufacture under training and prescription of another registrant?

Answer 8

• construct special trays - to take impressions
• repair acrylic components of removal appliances
• construct mouth-guards, bleaching trays and vacuum-formed retainers

Question 9

what can orthodontic therapists manufacture under prescription of a dentist?

Answer 9

• insert removable ortho appliciances
• remove fixed appliances, adhesive and cements
• fit ortho headgear and facebows adjusted by the dentist
• identify, select and place auxiliaries, brackets and bands
• fit bonded retainers
• insert and remove arch wires
• repair acrylic components of ortho appliances

Question 10

what can dental hygienists manufacture?

Answer 10

re-cementing a crown with temp

Question 11

what can dental hygienist and therapists manufacture with prescription of a dentist?

Answer 11

carry out tooth whitening

Question 12

what can dental therapists do with medical devices?

Answer 12

re-cement a crown with temp
place pre-formed crowns on primary teeth

Question 13

what can dental technicians do under the MDR?

Answer 13

make dental devices to a prescription from a dentist or clinical dental technician

• also directly repair dentures

Question 14

what can dental technicians do with extra training, with the dentist?

Answer 14

• help with the fit chairside
• take impressions
• record facebows
• record occlusal registrations

Question 15

who are Clinical Dental Technicians, according to the GDC?

Answer 15

registered professional who can prescribe and provide dentures

Question 16

what may CDT’s do under prescription of a dentist?

Answer 16

• provide, fit and perform procedures on removal appliances
• provide sport mouth guards
• provide anti-snoring devices
• provide tooth whitening
• re-cement crown with temp
• replace implant abutments for removable dental appliances

Question 17

what can dentists do?

Answer 17

all above treatments of other dental professionals

• prepare treatment plans
• prescribe and provide ortho appliances
• prescribe and provide fixed and removable prostheses

Question 18

with extra training, what can dentists do?

Answer 18

• provide implants
• provide non-surgical cosmetic injectables

Question 19

how do you prescribe a fixed prosthesis at LDI?

Answer 19

green paper prescription
- must have tutors name and signature

Question 20

how do you prescribe a removable prosthesis at LDI?

Answer 20

blue paper prescription
- must have tutors name and signature

Question 21

what is the Statement of Manufacture? what must it include (7)?

Answer 21

• name and address of manufacturer
• data identifying the device
• a statment to say it is a custom-made dental appliance and intended for exclusive use by .. name of patient
• name of prescribing practioner
• name of practise
• specific characteristics of the products, as indicated via prescription
• a statment to say the device conforms to MDR 2002

Question 22

what does the prescriber need to comply with?

Answer 22

• the MDR
• make sure patient is aware they can request the statement of manufacture
• make the statement available to patient
• record if patient accepted the statement
• if patient did not accept, retain if for the lifetime of the appliance
• if statement not kept, it is punishable under Dentist Act, 1984

Question 23

what if the dentist uses a technician not based in the UK?

Answer 23

dentist is legally responsible for the safety of appliance
dentist must also ensure it meets MDR regulations

Question 24

what must all UK dental labs comply with? who do they register with to work legally?

Answer 24

the MDR

register with the MHRA
- medicines and healthcare regulatory agency