Topical Anesthetic for Dental use - Where to start to get it registered?

[medic61]

We are considering a product line of topical anesthetic with 20% benzocaine for dental use. Our company is ISO 13485 and FDA registered for medical devices but we have never carried a product like this so I am wondering where to start. I searched the FDA database for the brand name and even the supplier name (there are two brands, one spray another is swabbed on). I also searched by type of product and cannot find a product code, classification nor the suppliers names.
This is a popular item and I want to get it registered as well as start a technical file so I can add them to our scope next audit.
Is there not enough of benzocaine in it to concern the FDA? It is used in the mouth and I am sure there has to be a listing somewhere. I called the suppliers and they are not wanting to give me the information-I think my inquiry scared them.

Please help!
Medic

[Ajit Basrur]

Refer THIS one

[Ajit Basrur]

This one is one Benzocaine sprays

[medic61]

Thanks for a fast response Ajit, now that I have the product code I can proceed.
Your second post on the sprays probably is the reason the spray we are looking into only dispenses metered doses.

What occurs if I cannot find out which person holds the 510k? I looked on the FDA website and the names listed on the product. Is there is a requirement for me to know the K number?

Ajit there is one more product I have not had any luck with, .4% stannous flouride gel that is sold by the dentist for home health care. Years ago we discontinued it and now sales want's to add it back with our product expansion project.
Thanks again,
Medic

[MIREGMGR]

In Reply to Parent Post by medic61

What occurs if I cannot find out which person holds the 510k? I looked on the FDA website and the names listed on the product. Is there is a requirement for me to know the K number?

This is very confused. The material you are discussing is a drug, as indicated in Ajit's link above. The 510(k) process is used with (Class II) devices. A drug is not a device, and vice versa. The device regulatory process is not relevant to drugs.

For products like those you are describing, you need to review the drug regulatory process.

[Ajit Basrur]

I have moved the thread in FDA section

[medic61]

I hope these products are not too difficult to add to our ISO 13485 scope but time will tell. I usually start with the FDA listings to give me some idea of the EUclassification for ISO and the MDD. I admit this will be new to me so thanks to MIREGMIR for the link to the correct FDA webpage, seems like I have a lot to learn.
Thanks everyone.
Medic

[MIREGMGR]

In Reply to Parent Post by MIREGMGR

A drug is not a device, and vice versa. The device regulatory process is not relevant to drugs.

Most of the time.

Except for the exceptions.

Regulations on the device side are goofy as well. Several device types have more than one Product Code assigned. Some device types still don't have a properly descriptive Product Code at all. Some product codes are based on a single type of clinical equipment, some on a class of related clinical applications, others on the device's fundamental technology, and still others on the system with which an accessory is used. Some device types are Class I from one manufacturer, Class II from another.

The FDA's classification system is complex due to its legacy content and long period of creation by multiple uncoordinated participants. Its elements must have individually made sense when originally created, but now often don't. Much of it was created before anyone thought to build a set of coherent classification rules...not that such a set of rules necessarily generates perfect results, as exemplified by the imperfections of the EC and Canadian systems...which nonetheless are better. But, we have no choice but to work with the system we've got.