HELIOMOLAR(R) DENTAL RESTORATIVE— 510(k) K884588

Name: FDA 510(k) clearance K884588
Creator: U.S. Food and Drug Administration
Published: 1989-01-27

Substantially Equivalent

Williams Dental Co., Inc.

FDA 510(k) clearance K884588 for HELIOMOLAR(R) DENTAL RESTORATIVE, Substantially Equivalent on 1989-01-27. Applicant: Williams Dental Co., Inc.. Device class: 2.

Clearance details

Applicant: Williams Dental Co., Inc.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 1988-11-02
Decision date: 1989-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EBF

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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 Williams Dental Co., Inc.

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K893794 — APEXIT ROOT CANAL SEALER1989-11-29

Recalls naming K884588

K-number listed on FDA's recall record

Z-0665-2018 — Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501Class III·Terminated·Ivoclar Vivadent, Inc.·20170803
Z-0666-2018 — Heliomolar Refill 20x0.25g 140/A2, Product code 541502AN, Catalog number 541502Class III·Terminated·Ivoclar Vivadent, Inc.·20170803
Z-0667-2018 — Heliomolar Refill 20x0.25g 210/A3, Product code 541503AN, Catalog number 541503Class III·Terminated·Ivoclar Vivadent, Inc.·20170803
Z-0668-2018 — Heliomolar Refill 20x0.25g 110T, Product code 550559AN, Catalog number 550559Class III·Terminated·Ivoclar Vivadent, Inc.·20170803

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K884588.

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