MultiMatch Flow Chameleon AntiMicrobial Composite
Summary
Premier Dental Products Company received 510(k) clearance for MultiMatch Flow Chameleon AntiMicrobial Composite, a EBF device. Cleared on 2025-11-07.
Details
Source
510(k) Clearance
External ID
K253513
Action Date
2025-11-07
Status
Traditional
Category
device
Product Code
EBF
Product Description
MultiMatch Flow Chameleon AntiMicrobial Composite. Product code: EBF.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Premier Dental Products Company has received 3 total clearances in our database.
Premier Dental Products Company has 3 FDA actions in our database, including 3 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Premier Dental Products Company have FDA actions?
Premier Dental Products Company has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K253513" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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