Facility

DIATECH DENTAL INC

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

Key facts

8recalls · 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)	3012832388
Establishment type	Manufacture Medical Device
Location	497 LA MESA RD Mount Pleasant, SC, US 29464
Registration status	Active · expires 2026
Parent company	Coltene/Whaledent AG (owner-operator 9089944)
Brand names	Diatech Diamond Instruments; Alpen Diamond Instruments; Alpen; Alpen Speedster Zr Plus; DIATECH Z-Rex; Alpen Z-Rex; DIATECH

Activity by year

Recalls (8)

Devices registered here (1)

Instrument, Diamond, Dental
Product code DZP (opens in a new tab) · Class I · Dental · 21 CFR 872.4535

Recalls & enforcement

Class IIOngoing2023-01-20
Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button
Class IIOngoing2021-03-18
The incorrect dental pins were packaged and subsequently distributed.
Class IIOngoing2020-10-20
The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
Class IIOngoing2020-06-03
Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it difficult for the forceps to fit appropriately with dental dam clamps.
Class IITerminated2019-07-19
A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but different length.
Class IITerminated2018-08-21
ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
Class IITerminated2018-04-13
The products are labeled with an incorrect product number.
Class IITerminated2013-12-11
Coltne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging.

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. “DIATECH DENTAL INC (FEI 3012832388) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012832388-diatech-dental-inc/

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