MED610 appliances

[CoolHandLuke]

I'd like to ask you all if you have printed using Objet's MED610 clear acrylic before, and whether or not it is suitable for actual appliance printing or if its only viable like the website says "for up to 24 hrs"

it is seeming to pass very high standards, however theyve made it quite hard to follow what any of the standards mean.

if nothing else can you help me break down what their testing methods mean in legible english ?

 

[Jason D]

In simplest terms, the fda has only cleared the material for short term use (ie surgical guides, impressions trays etc).

Now, we all know that some of these materials are as good as (in some cases better than) the materials used in appliance fabrication every day in labs across the globe.
As I understand it the 24 hour number is based upon FDA, not the manufacturers estimation of the material.

Logic says it is only a matter of (a very short) time before these and other materials like them get cleared for long term use and we make our mouthguards, deprogrammers, ortho appliances etc out of them.

However, logic does not count for much when dealing with a government run organization. So only time will tell.

 

[2thm8kr]

So Luke since you are in Canada,thumb your nose at the FDA.

 

[CoolHandLuke]

from reading the MSDS it appears this material is only listed under US Federal control as containing Acrylic Monomer, the sheet says the whmis classification is D2A and D2B (which means according to google: carcinogenic and mutagenic among other things) and then when it needs to list what components of the material specifically are that, it lists "no components are listed"

so my head is swimming - this safety sheet is strange

 

[CoolHandLuke]

NFPS (national Fire Protection act) rates it as "moderate" health risk "slight" fire risk and "minimal" reactivity risk but if the product was carcinogenic or whatever, shouldnt that be higher ?

 

[CoolHandLuke]

reviewing what i think is the SARA311/312 list of chemicals Acrylic Monomer is nowhere to be found only Vinyl acetate monomer

 

[CoolHandLuke]

reviewed 4 different "lists" of controlled chemicals under US EPA and NONE of them list "Acrylic Monomer"

 

[bediener]

CoolHandLuke, send me your email address (mine is [email protected]) and I can send you the Declaration of Conformity for Med610. Med610 is currently ISO approved for short-term mucosal-membrane contact (up to 24 hours) and prolonged skin contact (more than 30 days). Med610 was evaluated following the standards for biological risks: Cytotoxicity, Irritation, Delayed type hypersensitivity, Genotoxicity, Chemical characterization, USP Plastic Class VI. The bottomline is 24-hours in the mouth at this point.

 

[CoolHandLuke]

now we're getting somewhere ....

so the EPA put this out in 2011: http://www.gpo.gov/fdsys/pkg/FR-2011-05-13/html/2011-11435.htm

effectively limits and controls the liquid form as being cytotoxic, however does specifically say

"
This rule was proposed in the Federal Register of November 5, 2010
(75 FR 68306) (FRL-8849-7). EPA received no public comments in response
to the proposal. Therefore, the Agency is issuing a final SNUR as
proposed that:
1. Revises the CA Index name for the chemical substance represented
by CAS No. 5117-12-4 from Morpholine, 4-(1-oxo-2-propenyl)- to 2-
Propen-1-one, 1-(4-morpholinyl)-.
2. Identifies those forms of the PMN substance that are exempt from
the provisions of the SNUR. These exemptions apply to quantities of the
PMN substance after it has been completely reacted (cured)."

meaning its cured form isn't part of the controlled substances protection, nor the regulations surrounding its uncured form.

and that leaves us with the problem of identifying a new MSDS for the cured form.

 

[Jason D]

did you try methyl methacrylate?

 

[CoolHandLuke]

reading more MSDS on objet's other materials and ran across this : Uncured ink will polymerize on exposure to light or heat rendering the product unusable. However, this reaction is not considered hazardous.

 

[CoolHandLuke]

did you try methyl methacrylate?

yes, number 80-62-6, and found this in extensive googling: http://www.epa.gov/iris/subst/1000.htm

II.B. Quantitative Estimate of Carcinogenic Risk from Oral Exposure
No data available.

so i don't get it

 

[CoolHandLuke]

methyl methacrylate has a different CAS number than "acrylic monomer" (5117-12-4)

 

[CoolHandLuke]

all these papers seem to be controlling the liquid form of the material, i might have to email objet and find that out.

 

[CoolHandLuke]

CoolHandLuke, send me your email address (mine is [email protected]) and I can send you the Declaration of Conformity for Med610. Med610 is currently ISO approved for short-term mucosal-membrane contact (up to 24 hours) and prolonged skin contact (more than 30 days). Med610 was evaluated following the standards for biological risks: Cytotoxicity, Irritation, Delayed type hypersensitivity, Genotoxicity, Chemical characterization, USP Plastic Class VI. The bottomline is 24-hours in the mouth at this point.

hi Barry. my thanks for the effort - but how does this declaration help me ? you copy-pasted the same words ive read over and over again.

i understand it is ISO approved for whatever but i want to know how they arrived at that number given all the risk assessment and such seems to me to affect the liquid form of the material, as once it is cured and no liquid remains the properties are different.

email me mistergodfrey at gmail.com

 

[bediener]

Correct, I copied the terms from the MED610 Biocompatibility Test Document that is in your email. I figured no need to reinvent the wheel, and that the explanation of the testing in the document plus references would be helpful as it focuses on cured Med610 properties. Lastly, although Med610 has medical approvals of ISO which the FDA may recognize, we do not declare Med610 has FDA approval.