Emanate Receives FDA Clearance for Perio PODS™

NEW YORK, Sept. 17, 2026 /CourierPR/ -- Emanate Biomedical, Inc., a company specializing in at-home oral care solutions, has received a significant regulatory milestone with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its Perio PODS™. This clearance marks the first FDA-approved at-home periodontal wound dressing designed to protect injured periodontal tissue following non-surgical periodontal procedures.

The Perio PODS™ device consists of single-use, patient-matched dental trays preloaded with engineered hydrogel. These trays are intended to form a temporary physical barrier, preventing further irritation and promoting healing. Approximately 31 million non-surgical periodontal procedures, including scaling and root planing and periodontal maintenance, are performed annually in the United States. Until now, there has been no FDA-cleared at-home periodontal wound dressing to protect treated tissues during the critical healing phase.

Jarret Fass, Co-Founder and CEO of Emanate, emphasized the importance of this clearance. "Non-surgical periodontal procedures treat periodontitis, a chronic disease, but create an acute wound. The healing of this wound is essential for a successful outcome. Yet, dentistry has historically lacked a purpose-built solution to protect treated tissues at home during the critical healing phase. FDA clearance of Perio PODS represents a significant step toward addressing this longstanding treatment gap."

In a separate 45-patient investigational randomized controlled trial conducted at the ADA Forsyth Institute, a globally recognized oral health research institution, use of Perio PODS under a study-specific treatment regimen was associated with significantly greater reductions in periodontal pocket depth and multiple markers of gingival inflammation compared to periodontal debridement alone. These findings highlight the potential of Perio PODS to advance periodontal healing following treatment.

Emanate has also assembled a Clinical Leadership Council comprising internationally recognized researchers and clinical leaders, including Dr. Panos Papapanou, Dr. Georgios Kotsakis, Dr. Robert Mongrain, Dr. Curry Leavitt, and Dr. Jason Stoner. Dr. Stoner, a nationally recognized periodontist and clinical leader, noted, "For decades, periodontists have had limited ability to protect treated periodontal tissues during the critical healing period after a patient leaves the office. Perio PODS gives us a practical way to address that gap and fits naturally into existing periodontal treatment workflows."

Emanate is preparing for a phased U.S. launch of Perio PODS in 2027. The company has already secured the support of leading periodontal and general dental practices across the U.S. through its growing Launch Partner Program. Emanate has raised $11 million to date from Pierpoint Capital.

Perio PODS is a patient-matched periodontal wound dressing consisting of single-use dental trays preloaded with engineered hydrogel. The hydrogel is a water-based polymer matrix containing chlorhexidine digluconate as a preservative and specifically formulated for use within the Perio PODS system. Perio PODS is prescribed by a dental professional for at-home use twice daily for 30 minutes for up to 15 days following a planned non-surgical periodontal procedure. Each patient’s Perio PODS are custom manufactured by Emanate using a digital impression captured by the dental practice and supplied to the practice for administration immediately following the procedure and subsequent at-home use.

Emanate Biomedical, Inc., founded in 2019 by Dr. Peter Zegarelli, a dentist with over 40 years of clinical experience, aims to address the most consequential unmet needs in oral health. The company’s patent-protected PODS™ technology combines patient-matched, single-use dental trays with preloaded engineered hydrogel for applications across oral diseases and wounds.