K-number	K251775
Device name	RODIN Cement
Applicant	Belport Company, Inc., Gingi-Pak
Product code	EMA
Device class	Class II
Decision date	Sep 2, 2025
Decision	Substantially Equivalent
Regulation	872.3275

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

RODIN Cement is a dental luting cement available in two formulations: a light-cure veneer cement for permanent adhesive luting of glass-ceramic, lithium disilicate, and composite veneers/inlays/onlays with thickness <2mm, and a dual-cure luting cement for adhesive luting of inlays, onlays, partial crowns, crowns, and bridges. The dual-cure formulation requires additional light-cured adhesive for opaque ceramic restorations.

Technological characteristics

Not stated in this summary.

Test standards cited

Not stated in this summary.

Substantial equivalence argument

Not stated in this summary. The document confirms substantial equivalence to legally marketed predicate devices or devices predating the 1976 Medical Device Amendments, but does not provide the specific reasoning, comparative data, or predicate device information supporting the equivalence determination.

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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RODIN Cement

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