K-number	K260430
Device name	Porcelain Etch Gel
Applicant	Belport Company, Inc., Gingi-Pak
Product code	KLE
Device class	Class II
Decision date	Apr 10, 2026
Decision	Substantially Equivalent
Regulation	872.3200

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

Porcelain Etch Gel is used for extraoral etching of resin bonded porcelain and ceramic restorations such as veneers, crowns, and inlays prior to bonding and cementation. It is a Class II dental device classified as a Resin Tooth Bonding Agent.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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Porcelain Etch Gel

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