First Impression TM
510(k) K894282
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK894282 | Date22 Dec 1989 | 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- Withdrawn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
- ELW
- Device Class
- Class II
- Regulation
- 21 CFR Part 872.3660
- Advisory Committee
- Dental
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
First Impression TM is a dental impression material classified as a Class II medical device under FDA regulation number 872.3660. It is substantially equivalent to a predicate device and has received traditional 510(k) clearance from the FDA.
The device is manufactured by Coe Laboratories, Inc. and is identified by the product code ELW and K-number K894282. It is supplied as a non-sterile, single-use or reusable material depending on formulation, intended for use in dental settings, with no MRI safety information provided in the data.
Other devices from Coe Laboratories, Inc.
Questions
AI-generated answers, 19 Sep 2026
Is First Impression™ dental impression material reusable or single-use, and how does that affect my workflow?
First Impression™ is available in both single-use and reusable formulations, depending on the specific variant. The reusable versions allow for multiple uses within their intended shelf life, which can reduce waste and costs in busy dental practices. However, single-use versions may offer convenience for one-time procedures or when cross-contamination concerns are a priority. Always check the packaging or manufacturer’s instructions for the specific formulation you’re using to confirm its reuse eligibility.
What storage conditions are recommended for First Impression™ to maintain its performance?
Since First Impression™ is non-sterile, it should be stored in a clean, dry environment away from direct sunlight and extreme temperatures. The manufacturer’s guidelines (not explicitly detailed here) typically recommend room temperature storage, but always verify the specific storage instructions on the packaging or with Coe Laboratories, Inc. Proper storage ensures the material retains its intended properties for accurate dental impressions.
How do I determine which model or variant of First Impression™ is best suited for my dental procedures?
The product code ELW and the K-number K894282 indicate this is a dental impression material, but the exact models or formulations (e.g., single-use vs. reusable) aren’t specified beyond the general classification. To select the right variant, consult Coe Laboratories, Inc. or refer to their technical documentation, as different formulations may be optimized for specific applications like crowns, bridges, or orthodontics. Clarifying the intended use with the manufacturer ensures compatibility with your clinical needs.
Does First Impression™ have any MRI safety considerations I should be aware of?
The provided data does not include any MRI safety information for First Impression™. If MRI compatibility is a concern for your practice—such as when patients may require imaging after dental procedures—you should confirm with Coe Laboratories, Inc. whether the material contains any metallic or non-MRI-safe components that could interfere with scans.