# K031819: Dio-Dent 10 Dental Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: Msq (M2), Ltd.
- Decided: Oct 30, 2003 after 140 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922901 (1992). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983058: Ceralas D Laser System, Model # Ceralas D15, Ceram Optec, Inc. (1998) Summary page 1.
- K991891: Ceralas Diode Laser System, Model Ceralas D15, Ceram Optec, Inc. (1999). Our reading of the summary gave K991591, FDA’s number for Biothane Patient Restraint (Bioplastics). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ceralase D980m Diode Laser System, Model D15”.
- K993002: Ceralas D 980NM Diode Laser System, Model D15, Ceram Optec, Inc. (1999) Summary page 1.
- K993911: Ceralas D Diode Laser System, Model D15, D25,D50, Ceram Optec, Inc. (2000) Summary page 1.
- K022351: Diodent Dental Laser System, Continuum Electro-Optics, Inc. (2002)
- K000990: Opus 10 Dental Diode Laser, Opusdent, Ltd. (2000)
- K011769: Opus 10 (with Tooth Whitening Application), Model 2ND, Opusdent, Ltd. (2001)

## Indications for use
The Dio-Dent 10 Dental Diode Laser System is intended for incision, excision, ablation, vaporization and/or coagulation (hemostasis) of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). In addition, the system is intended for teeth whitening. The Indications for Use of the Dio-Dent 10 Dental Diode Laser System include: Cosmetic Dentistry Light activation for bleaching materials for teeth whitening, Laser-assisted bleaching/whitening of the teeth Endodontology Pulpotomy, Pulpotomy as an adjunct to root canal therapy Periodontology Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) Oral Soft Tissue Surgery Biopsy, Operculectomy, Gingivectomy, Gingivoplasty, Oral papillectomy, Leukoplakia, Treatment of aphthous ulcers, Fibroma removal, Frenectomy, Frenotomy, Tissue retraction for impressions, Incising and draining of abscesses, Draining fistulas, Exposure of unerupted partially erupted teeth, Lesion (tumor) removal, Implant recovery, Implant uncovering, Gingival troughing, Crown lengthening, Hemostasis of donor site, Coagulation and decontamination of extraction sites, Removal of granulation tissue, Degranulation of infrabony defects, Laser assisted flap surgery, Vestibuloplasty, Removal of hyperplastic tissues, Debridement of diseased epithelial lining

Source page: https://510kreport.com/device/K031819
Methodology: https://510kreport.com/methodology