Imz O-Ring Attachment

FDA 510(k) K883211 · Interpore Intl.

Substantially Equivalent

510(k) numberK883211

Submission

Device name
Imz O-Ring Attachment
Applicant
Interpore Intl.
Irvine, CA, US
Received
July 29, 1988
Decision date
November 17, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
DZE – Implant, Endosseous, Root-Form
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3640
Specialty
Dental
Implant
Yes

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K952167Imz Bone Tack SystemDZL · Traditional 11/21/1995SE
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Questions and answers

When was Imz O-Ring Attachment cleared by the FDA?

Imz O-Ring Attachment (K883211) received a 510(k) decision of Substantially Equivalent on November 17, 1988, 111 days after the submission was received.

What is the product code of K883211?

The FDA product code is DZE – Implant, Endosseous, Root-Form, a Class II (moderate risk) device regulated under 21 CFR 872.3640.