Facility

COSMEDENT, INC.

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	1450653
Establishment type	Repack or Relabel Medical Device
Location	4646 N. RAVENSWOOD AVE. CHICAGO, IL, US 60640
Registration status	Active · expires 2026
Parent company	COSMEDENT, INC. (owner-operator 1450653)
Brand names	BulkFill

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (1)

Material, Tooth Shade, Resin
Product code EBF (opens in a new tab) · Class II · Dental · 21 CFR 872.3690

Recalls & enforcement

Class IIOngoing2023-07-20
Reports were received the elastomer cup material is crumbling.
Class IITerminated2017-09-28
Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.

FDA inspections (1)

NAI2017-06-07
No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

All facilities operated by COSMEDENT, INC.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “COSMEDENT, INC. (FEI 1450653) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1450653-cosmedent-inc/

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