Classification of Dental Implants - MDD 2.4. Rule 8

Question regarding dental implants classification
"MDD 2.4. Rule 8 states
All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended:
- to be placed in the teeth, in which case they are in Class IIa, "
Does "to be placed in the teeth" mean aslo in the jaw bone, as dental implants are actually placed in the bone?
In other word are dental implants class IIa?

Guidance on Classification can be found in MEDDEV 2.4, and the most useful (specific) information is in Part 2. For Rule 8, Note 2 on page 29 (following page) seems to indicate dental implants going into the bone are Class IIb, but better to read yourself and confirm.

Peter,
Thanks for trying but that was exactly my question:I quoted the same rule and note and I also read it "to indicate", however it is ambiguous since the note says implants going into teeth, while in fact dental implants go into the bone in the place where a tooth used to be.....

Can I check we are both looking at the same note in the MEDDEV, which says:

Note 2: Implants without bioactive coatings intended to secure teeth or prostheses to the maxillary or mandibular bones are in Class II B following the general rule

In layman's terms this would seem to be saying that devices for securing a tooth or false tooth to the bone would remain Class IIb.

Perhaps the point of confusion is the phrase "dental implant".

Under the MDD, even normal dental fillings or braces are considered implants (see the definition in Annex IX, Section 1.2). When you say "dental implant" I think you are probably thinking of a more specific item, but "dental implant" under the MDD is much broader. But obviously Class IIb is too high for a normal dental filling, so Rule 8 adds a provision that if the implant is only in the tooth, the class is dropped to IIa.

I found also a DTA "Dental Device Risk Classification Chart", of course not formal but it seems to follow the thinking.

Hope this helps.

Peter,
Thank you for bearing with me. I have checked your reference and it is quite clear but your source is the MDD Guidelines , not the Directive itself. The original wording in the Directive https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0042:EN:HTML is:
"2.4. Rule 8
All implantable devices and long-term surgically invasive devices are in Class IIb unless they are intended:
- to be placed in the teeth, in which case they are in Class IIa,
- to be used in direct contact with the heart, the central circulatory system or the central nervous system, in which case they are in Class III,
- to have a biological effect or to be wholly or mainly absorbed, in which case they are in Class III,
- or to undergo chemical change in the body, except if the devices are placed in the teeth, or to administer medicines, in which case they are in Class III."
And there are no notes.
Hope we can trust the Guidance although it has a disclaimer up front saying it is not biding ..blah..blah
Thank you again for helping me out on this

I'm late on the reply, but I was just asking myself the same question, so found this thread as part of my internet search! The way that Rule 8 reads can imply that an implant in the teeth is a IIa. I then recalled a Dental Device Risk Classification Chart. I looked up the FDA product code for the Implant, Endosseous, Root-Form (DZE), and this chart confirms it is a Class IIB.

Here is the link:
https://ec.europa.eu/health/medical-devices/files/recast_docs_2008/responses/039-r-2_en.pdf

Everything that is placed into the teeth, is Class IIa (fillings, inlays, onlays, ...)

Everything that is implanted into bone material is Class IIb

We used to offer a TAD implant that was placed in the bone above the teeth. It was a Class IIb.
Hate to say it but we discontinued it as the tech file review by the NB was costing too much and the profit margin was not that great.

Picking up on those interested, and on this thread...MDRs affecting dental implants?