Z-1145-2014Class II

Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical...

Name: Z-1145-2014 Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical...
Creator: China Daheng Group Inc.
Published: 2013-07-15
License: https://open.fda.gov/license/

China Daheng Group, Inc. / initiated 2013-07-15 / Terminated / root cause: manufacturing process

FDA source

China Daheng Group Inc. began a recall of Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments on 2013-07-15. FDA classified it as Class II and gives the reason as "Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). For example, the user manual did not contain calibration procedures for Denlase or Penlase Lasers". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1145-2014
Classification: Class II
Status: Terminated
Initiated: 2013-07-15
Posted: 2014-03-14
Terminated: 2015-04-17
Recalling firm: China Daheng Group, Inc.
Product: Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.
Product code: LYB
Reason for recall: Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). For example, the user manual did not contain calibration procedures for Denlase or Penlase Lasers
Root cause tag: manufacturing process
FDA root cause: Radiation Control for Health and Safety Act
Action: China Daheng Group, lnc.(CDH}, ensures tha they will execute seriously their plans for the repair of their electronics products Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System. China Daheng Group, lnc.(CDH}, will send their updated 238 pes of Diode Laser Therapy System operation manual and 200 pes of Dental soft Tissue Laser brochure to their Distributor. They will pay all of their expense including manufacture cost and freight cost. China Daheng Group, lnc.(CDH}, will remedy these defects through changing the manuals and brochures for their distributor, purchasers and any subsequent transferee. They will make new version manuals and brochures. Then they will send them to their customers and distributor after finishing inspection by their quality department according to the procedure Denlase-Y0029A for manual and brochure inspection. CDRH approves the CAP subject to the following condition: .Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification.
Quantity in commerce: 238
Distribution: CA, KS, IL, PA, NJ, WI, WY, KY, FL and NY India, Indonesia, Turkey, Denmark, and France,
Product codes and lots: Denlase and Penlase Dental Laser Systems.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1145-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1145-2014	Class II	Terminated	Voluntary: Firm initiated	2014-03-26	2014-03-14

Product code LYB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)