A&E Bioceramic Co., Ltd.
TW Last updated 22 Oct 2026
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- 1
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- FDA 510(k)
- FDA recalls
- 0
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What A&E Bioceramic Co., Ltd. makes
A&E Bioceramic Co., Ltd. manufactures zirconia blanks used in dental restorations, including crowns and bridges, under models such as EZBUCT02, EZBUCT04, and others. These blanks serve as pre-sintered substrates for dental technicians to shape and customize for patient-specific applications.
The company’s zirconia blanks are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The products are listed in the FDA’s 510(k) database, reflecting their authorised status for dental use in the United States.
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- TW