K-number	K243721
Device name	Self Sealing Sterilization Pouches
Applicant	Wellmed Dental Medical Supply Co., Ltd.
Product code	FRG
Device class	Class II
Decision date	Apr 25, 2025
Decision	Substantially Equivalent
Regulation	880.6850

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

Self Sealing Sterilization Pouches are intended to enclose medical devices for sterilization by healthcare providers and maintain sterility of the enclosed device until use. They are designed for sterilization of dental instruments (excluding complex devices with lumens/channels) using steam or ethylene oxide (ETO) methods, maintaining sterility for up to 6 months post-sterilization with a maximum shelf life of 3 years from manufacture.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

Researching this as a predicate?

Want a transparent AI-ranking score, AI-discovered related predicates, ongoing safety and warning-letter monitoring, full predicate chain lineage, and a drafted SE rationale — all saved to your own project? That's what an account adds.

Start free trial →

Self Sealing Sterilization Pouches

Everything you need for a 510(k) submission. Nothing you don't.