HYTAC APLITIP/HYTAC OSB— 510(k) K962442

Substantially Equivalent

Espe GmbH & Co. Kg.

FDA 510(k) clearance K962442 for HYTAC APLITIP/HYTAC OSB, Substantially Equivalent on 1996-09-11. Applicant: Espe GmbH & Co. Kg.. Device class: 2.

Clearance details

Applicant: Espe GmbH & Co. Kg.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1996-06-24
Decision date: 1996-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seefeld, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

K262202 — Cerasmart Forte2026-09-10
K261695 — Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)2026-08-31
K261485 — Tetric plus Fill; Tetric plus Flow2026-07-01
K262228 — Transcend Bulk Fill Flowable Composite2026-07-01
K261246 — SRGC-062026-06-18

More clearances from Espe GmbH & Co. Kg.

K974231 — POSITION PENTA, POSITION PENTA QUICK1998-01-29
K973513 — SINFONY DENTIN, OPAQUE-DENTIN, ENAMEL, ENAMEL MODIFIER, TRANSPARENT OPAL,SINFONY MAGIC MODIFIERS, SINFONY OPAQUER1997-12-22
K973262 — KETAC-FIL APLICAP PLUS1997-11-17
K972892 — CAVIT-LC1997-10-02
K963735 — COJET SYSTEM1996-11-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.