Phosphoric Acid Etching Gel
Summary
Rizhao Huge Biomaterials Company, Ltd. received 510(k) clearance for Phosphoric Acid Etching Gel, a KLE device. Cleared on 2022-09-12.
Details
Source
510(k) Clearance
External ID
K221450
Action Date
2022-09-12
Status
Traditional
Category
device
Product Code
KLE
Product Description
Phosphoric Acid Etching Gel. Product code: KLE.
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. Rizhao Huge Biomaterials Company, Ltd. has received 11 total clearances in our database.
Rizhao Huge Biomaterials Company, Ltd. has 11 FDA actions in our database, including 11 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 Rizhao Huge Biomaterials Company, Ltd. have FDA actions?
Rizhao Huge Biomaterials Company, Ltd. has 11 FDA actions in our database, including 0 recalls and 11 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K221450" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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