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Prosthetic Silicone Materials

TECHNOVENT LIMITED · Model Softening Agent – 100g · UDI-DI 05060483012131

GBI
10
510(k) clearances
0
Adverse events
0
Recalls
6
Facilities

Description

Silicone materials for manufacture of adhesive or implant retained external maxillofacial materials. The softening agent is an additive to reduce the hardness of cured M511 silicone rubber. The Gel Part B is an alternative cross-linker for M511 which creates a gel material, rather than a rubber.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.