Identifiers
- 510(k) Number
- K010994 FDA 510(k)
- FDA Product Code
- ELW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3660 FDA 510(k)
- Regulation Number
- 872.3660 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Take One Bite Modified is an impression material device, classified as a Material, Impression, intended for use with preformed impression trays. It is designed to capture the anatomical structure of a patient’s teeth and gingiva, producing accurate models for dental study or fabrication of restorative prosthetics such as inlays or dentures.
This device is supplied as a reusable impression material, typically used in dental clinics. It is regulated under FDA 510(k) clearance (K010994) and falls under the classification of Class II (872.3660). The product is intended for single-use applications per impression, ensuring clinical accuracy and patient safety. No specific sterility or MRI safety information is provided in the data.
Frequently asked questions
Is the Take One Bite Modified impression material reusable or single-use, and how does this affect its clinical use?
The Take One Bite Modified is designed for single-use per impression to ensure clinical accuracy and patient safety. While the material itself may be reusable in terms of packaging or storage, each impression requires a fresh application to maintain precision in capturing the patient’s dental anatomy for study models or restorative prosthetics.
What types of dental restorations or models can this impression material be used to create?
This impression material is intended for capturing the anatomical structure of a patient’s teeth and gingiva to produce accurate models for dental study or fabrication of restorative prosthetics, such as inlays or dentures. It is specifically designed to work with preformed impression trays, ensuring detailed impressions for downstream applications.
How is the Take One Bite Modified supplied, and what should clinicians consider when storing it?
The Take One Bite Modified is supplied as a reusable impression material for dental clinics, though each impression requires a fresh application. Since no specific sterility or storage instructions are provided in the data, clinicians should follow standard dental protocols for handling impression materials, ensuring proper sealing and protection from contamination or environmental exposure to maintain efficacy.
What regulatory pathway does this device follow, and what does that mean for its use in clinical settings?
The Take One Bite Modified is regulated under FDA 510(k) clearance (K010994) and classified as Class II (872.3660). This means it has undergone a premarket review to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets safety and effectiveness standards for dental impression materials. Clinicians can rely on this pathway as evidence of its regulatory compliance for use in capturing dental impressions.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: TAKE ONE BITE MODIFIED by KERR CORP. | FDA 510 (k) Summary, Take One Bite Modified 510 (k) FDA Premarket Notification K010994 KERR ..., Kerr Corporation FDA 510 (k) Dental Products - Latest 2026, KERR TAKE 1 ADV BITE REGISTRATION #34148 (2) - Dentavision
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K010994 | Class II | Active |
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Manufacturer
- Manufacturer
- Kerr Corporation
- FDA Applicant
- Kerr Corp.
Sources (1)
- FDA 510(k) K010994 24 fields · synced Sep 19, 2026