O Butment
by O Co., Inc. 510(k)
Active
510(k) K903211
Overview
The O Butment is a Class 2 dental device with product code DZE. It is designed for use in dental applications as an abutment component.
The device is supplied by O Co., Inc. and is cleared through the Traditional 510(k) pathway. It is authorized under FDA 510(k) clearance numbers K884296 and K903211. The device is regulated under product code DZE and regulation number 872.3640.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903211 | Date29 Mar 1991 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DZE
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3640
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Other devices from O Co., Inc.
Questions
What is the O Butment used for in dental applications?
The O Butment is designed as an abutment component for dental applications, serving as a connecting element between the dental implant and the prosthesis to support and secure the final restoration.
How is the O Butment supplied and what are its regulatory approvals?
The O Butment is supplied by O Co., Inc. and has received FDA 510(k) clearance through the Traditional pathway with clearance numbers K884296 and K903211, making it substantially equivalent to predicate devices.
Is the O Butment a single-use device or can it be reused?
The device data does not specify whether the O Butment is single-use or reusable. Clinicians should refer to the manufacturer's instructions for use to determine the appropriate handling and disposal protocols for this device.
What sizes and models of the O Butment are available?
The provided device data does not include information about available sizes or models of the O Butment. For specific sizing options and model variations, please consult the manufacturer's product catalog or contact O Co., Inc. directly.