Home
Forms Library
CSM Implant - accessdata fda

CSM Implant - accessdata fda 2025

CSM Implant - accessdata fda Preview on Page 1

Show details

4.4 out of 5

46 votes

The document is a 510(k) summary for the CSM Internal-R Implant System, a dental implant intended for use in partially or fully edentulous mandibles and maxillae. It supports single or multiple-unit restorations and is made from titanium with a specific surface treatment. The device is classified as Class II and has been determined to be substantially equivalent to predicate devices, demonstrating similar safety and effectiveness without raising new questions regarding its use.

Here's how it works

01. Edit your form online

Type text, add images, blackout confidential details, add comments, highlights and more.

02. Sign it in a few clicks

Draw your signature, type it, upload its image, or use your mobile device as a signature pad.

03. Share your form with others

Send it via email, link, or fax. You can also download it, export it or print it out.

How to rapidly redact CSM Implant - accessdata fda online

Ease of Setup

DocHub User Ratings on G2

Ease of Use

DocHub User Ratings on G2

Dochub is the greatest editor for modifying your documents online. Adhere to this simple guide to edit CSM Implant - accessdata fda in PDF format online free of charge:

Register and sign in. Register for a free account, set a strong password, and proceed with email verification to start working on your forms.
Upload a document. Click on New Document and select the file importing option: upload CSM Implant - accessdata fda from your device, the cloud, or a protected link.
Make adjustments to the sample. Take advantage of the top and left-side panel tools to redact CSM Implant - accessdata fda. Insert and customize text, images, and fillable areas, whiteout unneeded details, highlight the significant ones, and provide comments on your updates.
Get your paperwork done. Send the sample to other people via email, create a link for faster document sharing, export the sample to the cloud, or save it on your device in the current version or with Audit Trail added.

Try all the benefits of our editor right now!

be ready to get more

Complete this form in 5 minutes or less

Get form

Got questions?

We have answers to the most popular questions from our customers. If you can't find an answer to your question, please contact us.

When are dental implants not a good idea?

If you regularly or subconsciously grind teeth, have uncontrolled diabetes, gum disease or jaw irradiation following a cancer diagnosis, these situations dont bode well for dental implants. Essentially, these conditions must first be dealt with or controlled to ensure the best possible outcome for implant restoration.

What are the negative effects of dental implants?

But occasionally something will go wrong and patients will experience dental implant problems years later. While it doesnt happen often, it is a possibility. These issues can turn into major sources of stress for those patients who do experience it.

What is the downside to dental implants?

As relatively high-risk class devices, dental implants are typically classified as IIb.

Who is responsible for dental implant failure?

The risks and complications you are taking for dental implants include infection, damage to other teeth, delayed bone healing, nerve damage, prolonged bleeding, jaw fractures and more. If you are willing to take these risks, dental implants might be right for you.

What implants are FDA approved?

There are two types of implants approved for sale in the United States: saline-filled and silicone gel-filled. Both types have a silicone outer shell. They vary in size, shell thickness, shell surface texture, and shape (contour).