[PRESS RELEASE]: Carestream Dental’s Manufacturing Site Completes FDA Inspection with No Observation

ATLANTA—Carestream Dental’s manufacturing facility in France has successfully completed a recent U.S. Food and Drug Administration (FDA) inspection with no Form 483 observations issued, a significant regulatory outcome that underscores the company’s unwavering commitment to quality, patient safety and regulatory excellence.

Receiving no Form 483 observations—commonly referred to as a “clean inspection”—indicates that the FDA found Carestream Dental’s systems and processes at its plant meet FDA expectations at the time of inspection.

“This result reinforces our customers’ confidence that the technology developed and manufactured at our facility is safe, properly documented and of high quality,” said Andrew Malcolmson, president, Imaging Technology Solutions, Carestream Dental. “A clean inspection is a testament to our long-term commitment to supporting safe and effective dental care.”

Carestream Dental designs, manufactures, markets, sells and services its own imaging systems and software, which are relied upon by dental professionals worldwide. Achieving a no observation outcome from the FDA is especially meaningful in an industry where product performance, reliability and patient safety are essential.

“For dental practices, DSOs and partners, this milestone is more than a regulatory success—it’s reassurance,” Norbert Gelé, global quality manager, Carestream Dental, said.  “It affirms that Carestream Dental remains focused on delivering solutions that meet the highest standards of quality while supporting clinicians in providing exceptional patient care.”

Carestream Dental remains committed to maintaining compliance with global regulatory requirements and to continuously enhancing its quality systems in service of its customers and the patients they serve. For more information about Carestream Dental, or any of its technology, visit carestreamdental.com.

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About Carestream Dental

Carestream Dental is a digital solutions leader built on more than 125 years of experience that’s committed to transforming dentistry, simplifying technology and changing lives. In this pursuit, it offers three brand portfolios that enable practice optimization, efficiency and growth: The Carestream Dental brand portfolio of world-class oral healthcare devices; the Swissmeda brand portfolio of market-leading clinical software and services; and the Sensei brand portfolio of best-in-class practice management software and services. These solutions connect industry partners, laboratories and payers to optimize oral healthcare providers’ preferred workflows. For more information, please visit carestreamdental.com.