Facility

Keystone Dental Inc.

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

Key facts

12recalls · worst Class II

—inspections in our data

—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)	3011936113
Establishment type	Manufacture Medical Device
Location	13645 Alton Pkwy Ste A Irvine, CA, US 92618
Registration status	Active · expires 2026
Parent company	Keystone Dental Inc. (owner-operator 9096980)
Brand names	Tri-Nex Dental Implant System

Activity by year

Recalls (12)

Devices registered here (2)

Abutment, Implant, Dental, Endosseous
Product code NHA (opens in a new tab) · Class II · Dental · 21 CFR 872.3630
Implant, Endosseous, Root-Form
Product code DZE (opens in a new tab) · Class II · Dental · 21 CFR 872.3640

Recalls & enforcement

Class IITerminated2019-02-22
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
Class IITerminated2018-05-01
The implants are mislabeled.
Class IITerminated2018-03-13
The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.
Class IITerminated2018-01-24
The cutting edge of tissue punches may be potentially damaged with small dents and nicks.
Class IIITerminated2017-10-16
A locking plastic abutment sleeve, used by dental technicians in dental laboratories to aid in the creation of the final restorative crown, was packed as a non-locking plastic abutment sleeve.
Class IITerminated2017-08-25
The recalled units are mislabeled with an incorrect expiration date. The expiration date printed on the label is 2202-06. The correct expiration date should be 2022-06.
Class IITerminated2017-06-20
Abutments are unable to accept the final abutment screw
Class IITerminated2017-06-16
An 8mm diameter bone tap was laser marked as 7mm diameter and was packed with a 7mm label.
Class IITerminated2017-03-09
Straight PrimaConnex Implants contained Tapered PrimaConnex Implants
Class IITerminated2016-09-15
Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)
Class IITerminated2013-03-11
Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled
Class IITerminated2011-07-05
Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,

All facilities operated by Keystone Dental 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. “Keystone Dental Inc. (FEI 3011936113) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3011936113-keystone-dental-inc/

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