Ibond Gluma Inside
FDA 510(k) K022612 · Heraeus Kulzer, Inc.
510(k) numberK022612
Submission
- Device name
- Ibond Gluma Inside
- Applicant
- Heraeus Kulzer, Inc.
South Bend, IN, US - Received
- August 6, 2002
- Decision date
- October 28, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K101617 | Flexitime Xtreme 2 Heavy Tray Cartridge Refill, Fexitime Xtreme 2 Light Tray Cartridge…ELW · Traditional | 09/07/2010SE |
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Questions and answers
When was Ibond Gluma Inside cleared by the FDA?
Ibond Gluma Inside (K022612) received a 510(k) decision of Substantially Equivalent on October 28, 2002, 83 days after the submission was received.
What is the product code of K022612?
The FDA product code is KLE – Agent, Tooth Bonding, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3200.