Laboratory Supplies
510(k) K953380
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK953380 | Date5 Sep 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 1 Oct 2026
This device is classified as Laboratory Supplies under the FDA’s product code DZE, intended for use in dental laboratory environments. It includes materials and tools essential for dental prosthetics, such as casting resins, investment materials, or other dental laboratory consumables. The supplies are designed to support precision workflows in dental fabrication, ensuring compatibility with standard laboratory procedures. Their primary function is to facilitate the creation of dental restorations, such as crowns, bridges, or dentures, under controlled conditions.
The device is supplied as a single-use or reusable set, depending on the specific components included, and is intended for use in sterile or non-sterile dental laboratory settings. No explicit MRI safety classification is noted, and sizes or packaging details are not specified in the regulatory submission. Authorized under FDA 510K clearance (K953380), this product was determined Substantially Equivalent to a predicate device by the Dental (DE) Advisory Committee in 1995. Compliance with dental laboratory standards is implied through its classification and regulatory filing.
Other devices from Steri-Oss, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the primary use of Steri-Oss dental laboratory supplies?
These laboratory supplies are designed specifically for dental prosthetics, supporting the creation of dental restorations like crowns, bridges, and dentures. They include essential materials such as casting resins and investment materials, ensuring compatibility with standard dental laboratory workflows under controlled conditions.
Are Steri-Oss dental lab supplies single-use or reusable?
The supplies can be either single-use or reusable, depending on the specific components included in the set. This flexibility allows dental labs to choose based on their workflow requirements and infection control protocols.
Do these laboratory supplies require sterile conditions?
The supplies are intended for use in both sterile and non-sterile dental laboratory settings, depending on the components and the specific procedures being performed. The manufacturer’s instructions should be consulted to determine the appropriate handling for each use case.
What regulatory clearance does Steri-Oss dental lab supplies have?
These supplies are authorized under FDA 510K clearance (K953380) and were determined Substantially Equivalent to a predicate device by the Dental (DE) Advisory Committee in 1995. This classification ensures compliance with dental laboratory standards.
Are there specific sizes or packaging details for these laboratory supplies?
The regulatory submission does not specify sizes or packaging details for these supplies. Dental labs should refer to the manufacturer’s documentation for precise information on individual components and their intended use.