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Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K261802

510(k) cleared

Glidewell Denture Base Resin

Prismatik Dentalcraft, Inc. · Aug 27, 2026 · K261802

FDA cleared the Glidewell Denture Base Resin from Prismatik Dentalcraft, Inc. on Aug 27, 2026 under K261802, a traditional 510(k). The device falls under product code EBI, Resin, Denture, Relining, Repairing, Rebasing, regulated at 21 CFR 872.3760 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 1, 2026. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

Prismatik Dentalcraft, Inc. has 3 other decisions in the tracker over the last 12 months: K262239 (Obsidian® Press Over Zirconia), K254283 (BruxZir® Shaded 16 PLUS), K252582 (Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems).

Questions & Answers

What did FDA clear under K261802?

K261802 is the FDA 510(k) for Glidewell Denture Base Resin, submitted by Prismatik Dentalcraft, Inc.. FDA's decision date was Aug 27, 2026, under product code EBI (Resin, Denture, Relining, Repairing, Rebasing).

Who makes the Glidewell Denture Base Resin?

Prismatik Dentalcraft, Inc., based in Irvine, CA, is the applicant of record for K261802.

How long did the K261802 review take?

FDA received the submission on Jun 1, 2026 and issued its decision on Aug 27, 2026, 87 days later.

← All decisions in August 2026

Sources