Medical Device Amendments of 1976: FDA
Gave the ____ regulatory authority over medical and
dental devices
Standards for Dental Materials -ADA Seal: voluntary or Voluntary!
mandatory its for consumer products only.
Standards for Dental Materials Medical devices: classes Class I: least regulated, ex- prophy brush or paste
Class II: devices gain approval from FDA, meet performance standards, ex-
composite and amalgams
Class III: most regulated, require pre market approval, clinical data submission
before sold, ex- bone graft materials
Classification by location of fabrication (direct vs indirect)
direct -happens in the mouth at the moment, composite amalgam for teeth
indirect - crown or bridge (its not actually made in the mouth.
•Classification by use: restorative,
polishing agent
, denture,
specialty items
Classification: by Longevity •Permanent restorations
•Temporary restorations
•Interim restorations: long term temporary
Classification of Dental Caries & Restorations: ● Class I: The pits and fissures of posterior teeth
● Class II: The interproximal of posterior teeth
● Class III: The interproximal of anterior teeth
● Class IV: The interproximal & incisal edge of anterior teeth
● Class V: The gingival third of the facial and lingual surfaces of both anterior
and posterior
teeth
● Class VI: Incisal edge of anterior teeth
(there will be a question)
Purpose and indications for sealants? Who should Pit and fissure sealant material will literally flow into the deep pit and fissured
receive them? areas on occlusal surfaces and seal them from bacterial activity
-Deep grooves
-High risk for caries
-Presence of existing incipient caries
Contraindications for sealants Pit and fissure sealants are contraindicated on tooth surfaces having frank
caries or on surfaces that have well coalesced pits and fissures
it is very smooth it will not help
if there not at a risk for sealants
, DM Exam 1
What are the most common reason for failures? Operator error!!
failure to isolate,
wet field
uncooperative patient
defective product
Procedure to sealants 1. Listen to occlusion
2. Surface preparation: clean/remove debris
3. Isolation: rubber dam or cotton rolls
4. Dry the tooth, apply etchant, agitate etch, rinse well
5. Evaluate the etched tooth surface
6. Dry the tooth again
7. Apply a primer from a dentinal bonding system - acts as wetting agent to
improve
adhesion (optional)
8. Apply the sealant to the tooth surface, may need an explorer (Shepard's
hook or explorer)) to help
spread material
9. Polymerize the sealant (light cure)
10. Evaluate the sealant, attempt to dislodge
11. Floss between teeth to check for inter-proximal sealant
12. Check occlusion (listen)
two types of sealants unfilled -will wear down
filled -wont wear down and have to have a Burr
Polymerize the Sealant ●Light-Activated Sealants
Use amber eyewear or light shields during the curing process.
● Hold the tip of the curing light as close as possible to the tooth surface.
● Curing time is 20 seconds, but an additional 5 to 10 seconds are
recommended for each
surface.
● Some products change color when properly light-activated (watch loupe
light)
Chemically Activated Sealants (Rarely seen)
how long do you rinse etch? 30 seconds
*test question
how long does etch stay on? 15 to 20 seconds.
Dental sealants are effective in __________ dental caries Preventing
A)Reversing
B)Restoring
C)Preventing
D)Proliferating
, DM Exam 1
Properly etched and dried enamel appears chalky white
A)Shiny and pale•
B)Chalky white
C)Dull grey
D)Peachy keen
After placement, the sealant should be checked for: Both
A)Hyper occlusion of occlusal contacts
B)Interproximal contacts bonded together
C)Both
D)Neither
In the United States, standards for dental materials are ADA (American Dental Association)
developed and administered by
the:
A) FDA (Food and drug administration)
B) ADA (American Dental Association)
C). AADR (American Association for Dental Research
D) OSHA (Occupational Safety and Health
Administration)
All of the following are reasons for a dental hygienist to Deciding which material is best for the patients restoration
have knowledge and
understanding of dental materials EXCEPT:
A) Explaining the different types of restorative materials
available to the patient
B) Assessing the patients oral condition
C) Deciding which material is best for the patients
restoration
D). Understanding the behavior of dental materials
An amalgam restoration located on the gingival third of V
tooth #3 would be a Class______ restoration.
1. I
2. II
3. III
4. IV
5. V
6. VI