PMMA Blocks for Dental Use
by Aidite (Qinhuangdao) Technology Co., Ltd.
510(k) K223477
Active
Valid until
No date given
FDA recalls
None foundTrust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK223477 | Date16 Feb 2023 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
| European Union | CE/MDR EUDAMED | Number— | Date— | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- EBG
- Device class
- Class II
- Regulation
- 21 CFR Part 872.3770
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
PMMA Blocks for Dental Use are polymethyl methacrylate (PMMA) dental resin blocks designed for fabrication of custom dental prosthetics. These blocks are used as a base material for creating removable dentures, partial dentures, and other dental restorations through heat-press molding techniques.
The blocks are supplied in sterile packaging for single-use applications in dental laboratories. They comply with FDA 510(k) clearance under the Traditional pathway, with a decision classification of Substantially Equivalent (SESE) for dental use. Sizes and formulations are standardized for precision in prosthetic fabrication, adhering to regulatory standards including the Medical Device Directive (MDD) and Medical Device Regulation (MDR)
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Questions
AI-generated answers, 18 Sep 2026
What types of dental restorations can these PMMA Blocks be used to create, and how are they applied in a dental lab?
These PMMA Blocks are specifically designed for fabricating removable dental prosthetics, including dentures and partial dentures. They are used in dental labs through a heat-press molding process, where the blocks are shaped and cured under heat and pressure to form custom-fitted restorations. The standardized sizes and formulations ensure precision and consistency in the final prosthetic.
Are these PMMA Blocks intended for single-use or can they be reused in a dental lab?
These PMMA Blocks are supplied in sterile packaging and are explicitly designed for single-use applications in dental laboratories. Reuse is not recommended or supported, as it could compromise sterility and the integrity of the prosthetic fabrication process.
What regulatory pathways have these PMMA Blocks undergone, and how does that affect their use in clinical settings?
The PMMA Blocks have received FDA 510(k) clearance under the Traditional pathway, classified as Substantially Equivalent (SESE) for dental use, along with compliance under the Medical Device Directive (MDD) and Medical Device Regulation (MDR). This means they meet established safety and performance standards for dental prosthetics, ensuring they can be confidently used in clinical settings for removable restorations like dentures and partial dentures.
How should these PMMA Blocks be stored to maintain their quality and sterility before use?
Since these blocks are supplied in sterile packaging, they should be stored in a clean, dry environment away from direct sunlight, extreme temperatures, or sources of contamination. The packaging should remain intact until immediately before use to preserve sterility and prevent exposure to moisture or dust, which could compromise the material’s integrity for prosthetic fabrication.