FDA device listing

Tongue ScraperFor Oral Care;YANDY;2PCS;Plastic parts PP;Rubber parts TPR

FDA device listing 1865257246 · Pesitro Healthcare Products Co., Ltd.

Key facts

Proprietary names Tongue ScraperFor Oral Care;YANDY;2PCS;Plastic parts PP;Rubber parts TPR
Owner/operator Pesitro Healthcare Products Co., Ltd.
Owner/operator number 10031762
Product codes LCN
Device names LCN - Scraper, Tongue
Device class Class I
Classification regulations (21 CFR) 872.6855
Review panels Dental
Registered establishments PESITRO HEALTHCARE PRODUCTS CO., LTD.
Establishment registrations 3008262609
FEI numbers 3008262609
Establishment operations Contract Manufacturer, Foreign Exporter, Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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