Facility

SDS de Mexico S. de R.L. de C.V.

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)	3000368601
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	CIRCUITO SUR NUM. 31 MEXICALI, B.C. C.P. Baja California, MX 21395
Registration status	Active · expires 2026
Parent company	SYBRON DENTAL SPECIALTIES, INC. (owner-operator 9029565)
Brand names	Simile Composite; Artiste Nano Composite; NeoFil

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 IITerminated2015-02-11
Cases of Cure Sleeve labeled with part number 4513, which fits 13mm tips, have inner boxes labeled with part number 4500 which fit 7mm and 8mm tips. There is a low risk associated with the use of the product as the sleeve may tear causing a potential for cross contamination.
Class IITerminated2013-06-06
The firm initiated the recall of AOA Mini RPE Screw Assembly, because it may be missing a complete weld joining one side of the arm with the screw body. Herbst, MARA and Fixed Metal devices may be affected, because they contain an AOA Mini RPE Screw Assembly.

FDA inspections (1)

NAI2019-02-21
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.

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. “SDS de Mexico S. de R.L. de C.V. (FEI 3000368601) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3000368601-sds-de-mexico-s-de-r-l-de-c-v/

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