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Use caution Medical device recall · FDA · Published April 21, 2021

Dentech Rubber Dam Clamp KSK: Possible breakage during removal

Dentech recalls Rubber Dam Clamps KSK models with specific lot numbers due to possible breakage when removing parts for safety. Consumers should check their product codes and lot numbers.

🇺🇸 FDA recall #Z-1676-2021Medical deviceDentech ›
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Recalling firmDentech Corp.53 Shimizu-Cho,, Itabashi-Ku · Tokyo, Japan
✎ GovInfoNow plain-language explainer

What happened, in plain English

Dentech is recalling certain Rubber Dam Clamps KSK models because they may break when parts are removed for safety reasons. This could lead to injury if the clamp breaks during use. Read more at govinfonow.com/recall/62749-dentech-rubber-dam-clamp-ksk-possible-breakage-during-removal.

Source Summary by GovInfoNow · govinfonow.com/recall/62749-dentech-rubber-dam-clamp-ksk-possible-breakage-during-removal · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1676-2021

Cite this page

“Dentech Rubber Dam Clamp KSK: Possible breakage during removal.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62749-dentech-rubber-dam-clamp-ksk-possible-breakage-during-removal. Based on FDA recall #Z-1676-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1676-2021%22&limit=1).

Why it’s dangerous

The clamps may break when parts are removed for safety reasons, potentially causing injury if the broken parts are sharp or cause cuts during dental procedures.

Who’s affected

Dentech Rubber Dam Clamp KSK users who own the recalled models with specific product codes and lot numbers listed in the recall notice. Dental professionals and patients using these clamps during dental treatments are most at risk.

How to tell if you have this one

Check your product code (01012912, 01014912, 01019912, 01012913, 01014913, 01019913, 01012026, 01014026, 01019026) and lot numbers listed in the recall notice. The clamps are used for saliva and moisture prevention during dental treatments.

  • Brand
    Dentech
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify your product code and lot number to confirm if your clamp is recalled.

  2. Contact Dentech

    Reach out to Dentech for further instructions on how to handle the recalled clamps.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 4 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: named in the noticeKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of CA, MN, KY, WA and the countries of Russia, Libya, Moldova, China, Egypt, India, Canada, Guatemala, Iraq, Saudi Araba, Australia, Ukraine, Israel, Indonesia, Malaysia,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Kentucky, Minnesota, Washington.

Recall timeline

FDA terminated this recall 21 months after the firm started it.

1. Firm started the recall: Apr 21, 202112. FDA classified it Class II: May 25, 202123. Published in FDA’s Enforcement Report: Jun 2, 202134. FDA terminated the recall: Jan 12, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

How do I know if my clamp is affected?

Check your product code and lot number against the list provided in the recall notice.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1676-2021 (April 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1676-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA