# FDA recall Z-1676-2021

> **Dentech Corp.** · Class II · device recall initiated 2021-04-21.

## Product

Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination by saliva and moisture prevention during dental treatment.

## Reason for recall

Removing parts for safety reasons due to possible breakage.

## 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, UK, Singapore, South Korea, Georgia, Taiwan  Lithuania, Greece, Sweden, Netherland, France, Poland, Slovenia, Bulgaria, Norway and Romania.

## Key facts

- **Recall number:** Z-1676-2021
- **Recalling firm:** Dentech Corp.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-21
- **Report date:** 2021-06-02
- **Termination date:** 2023-01-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tokyo, N/A, Japan

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1676-2021

## Citation

> AI Analytics. FDA recall Z-1676-2021. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-1676-2021. Source: US FDA. Licensed CC0.

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