510(k) · Cleared
ClearedDentica Pulsed ND: Yag Laser Systems and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xintec Corporation · GEX Powered Laser Surgical Instrument
Cleared on Jun 17, 1997 after an 85-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Jun 17, 1997
- Review
- 85 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK971065 Dentica Pulsed ND: Yag Laser Systems and AccessoriesXintec Corporation · 1997
- Descendant · cites it directly · 0 of its ownK182930 PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K182930PerioLase Nd:YAG Pulsed Dental Laser SystemMillennium Dental Technologies, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971065 | Dentica Pulsed ND: Yag Laser Systems and Accessories | Xintec Corporation | 1997 | — |
| +1 | K182930 | PerioLase Nd:YAG Pulsed Dental Laser System | Millennium Dental Technologies, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182930 | PerioLase Nd:YAG Pulsed Dental Laser System | 2019 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K182930 (Millennium Dental Technologies, Inc., 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Dentica Pulsed Nd:YAG Laser System and accessories is indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue and cartildge. Soft tissue which may be encountered in surgical procedure includes skin, subcutaneous tissue, striated and smooth muscle, cartilage, mucous membrane, lymph vessels and nodes, organs and glands. Specific surgical specialties include: Dentistry Laser Curettage; Gingivectomy; Gingivoplasty…
Read the full statement (114 words)
The Dentica Pulsed Nd:YAG Laser System and accessories is indicated for
incision/excision, ablation, and coagulation (homeostasis) of soft tissue and
cartildge. Soft tissue which may be encountered in surgical procedure includes
skin, subcutaneous tissue, striated and smooth muscle, cartilage, mucous
membrane, lymph vessels and nodes, organs and glands.
Specific surgical specialties include:
Dentistry
Laser Curettage; Gingivectomy; Gingivoplasty; Incision and Excision
Oral Surgery
Frenectomy; Incisional and Excisional Biopsy; Incisional and Excisional
aphous ulcers; Incision of infection when used with antibiotic therapy;
Excision and ablation of benign and malignant lesions and conditions;
Homeostasis; Operculectomy, and Crown lengthening.
Ear Nose & Throat (ENT)
Head and Neck Surgery
Thoracic Surgery
Neurology (homeostasis only)
Dermatology
Plastic Surgery
General Surgery
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971065 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971065: Dentica Pulsed ND: Yag Laser Systems and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971065
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026