Tooth Whitening Product - Class I Medical Device in US - What is it in EU?

[Sarah Stec]

Do we know whether the OP's product is a laser or an LED light, and the concentration of hydrogen peroxide that they're using? OP, if you have some more information about your product, please share so we can help you a bit more.

The Biolase product's complete IFU seemed to have a bunch of different intended uses, some of which seemed to be pretty squarely "medical" uses. These may be what brought it into the scope of the medical devices directive.

A question for the group: Would H2O2 at that concentration bring it under the Biocides Regulation? I'm not totally familiar with it, so I was just wondering.

Also, a quick clarification: a product has to meet the definition of a medical device before going to the classification rules. It's not the classification rules that determine if a product is or is not a medical device, instead they point to which class of medical device. So you have to make sure you have a medical device in the first place before going to the rules in Annex IX of the MDD.

 

[rangani_rj]

Do we know whether the OP's product is a laser or an LED light, and the concentration of hydrogen peroxide that they're using? OP, if you have some more information about your product, please share so we can help you a bit more.

The Biolase product's complete IFU seemed to have a bunch of different intended uses, some of which seemed to be pretty squarely "medical" uses. These may be what brought it into the scope of the medical devices directive.

A question for the group: Would H2O2 at that concentration bring it under the Biocides Regulation? I'm not totally familiar with it, so I was just wondering.

Also, a quick clarification: a product has to meet the definition of a medical device before going to the classification rules. It's not the classification rules that determine if a product is or is not a medical device, instead they point to which class of medical device. So you have to make sure you have a medical device in the first place before going to the rules in Annex IX of the MDD.

HI,

The thinking of EC and Complete info regarding the H2O2 is here

http://ec.europa.eu/health/scientific_committees/opinions_layman/en/tooth-whiteners/index.htm#1


Regarding biocide ?
H2O2 have multiple action. It is also used as bleaching agent in textile industry, as household cleaning agent, tooth whitening agent, antiseptic on wound etc. All it depends on how it is used. 750,000 tonnes of H2O2 is produced and 50 % is used to bleach pulp in textile, in this regard it is controlled as high volume chemical - REACH regulation. Biocides are product - having 2-3 chemical simultaneously. The categories of products that would be considered as Biocide are given in Annex V of Biocide directive (REGULATION (EU) No 528/2012), mainly 4 group - Disinfectant, Preservative, Pest control and other Biocidal. Further the active chemical whose concentration is fixed in biocidal products are given in annex I of biocide directive and EC is amending the annex I whenever new chemical need to be regulated in Biocidal products. This does not contain H2O2 (But use of H2O2 in house hold cleaning product may make final Product a biocide - Product-type 2 (Disinfectants for cleaning floors, bathing area etc.)). If H2O2 is killing bacteria at higher concentration it does not make it Biocide as individual, many chemicals kill bacteria at higher concentration but they are not worthy to be used as biocide at that concentration. Biocide should have proven efficacy according to directive and they are killing organism at very low concentration having minimal environmental exposure. Further, Only organic peroxide are considered as Biocide (and its mechanism is differ from H2O2). Many chemical have dual effect, consider "Warfarin". It is also used as drug (anti-coagulant) at concentration 1 mg and as biocide (750 mg/kg, COMMISSION DIRECTIVE 2010/11/EU, amending Biocide directive (98/8/EC) annex I).

So it all depends on How H2O2 is used.

 

[bio_subbu]

Good explanation.

I found the the concentration of H2O2 in products for teeth whitening gel is between 16-25%. This may not make it Cosmetic.

Regarding light I have two doubts

The light source in case of Biolase is LASER - which might be transferring energy in body (though as a side effect here) so it could be considered as as MD according to rule 9 of MDD. I am not sure.

In case of Philips Zoom its LED - Range of light spectrum is 400-500 nanometer and its visible light, so may not be passing energy to body tissue. Just accelerating the reaction in Gel.

Cheers,

Please refer attached Irish Dental council "Tooth Whitening - Information sheet (Sept 2012)" "In particular ?The assessment concludes that a limit of 0.1% hydrogen peroxide (present or released) is safe for products sold directly to consumers. Products containing more than 0.1% and up to 6% hydrogen peroxide (present or released) should only be administered by a dental practitioner. Because of the increasing risks of acute and long-term effects, tooth whitening products containing more than 6% hydrogen peroxide are not considered safe for use by the consumer."

Therefore with this product containing Hydrogen Peroxide levels of 16-25%, it is not permitted for use as a teeth whitening or bleaching product and cannot be marketed as such.

The laser light would only be considered a medical device if its used for a medical purpose and meeting the definition of medical devices per Article 1a) of Medical Device Directive 93/42/EC. As such, if the laser light were being used to accelerate the whitening of teeth, it is unlikely that it would be CE marked as a medical device.