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510(k) Data Aggregation
K Number
K990680Device Name
DENTEC LD 15 DIODE LASER
Manufacturer
DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H.
Date Cleared
1999-07-30
(150 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DENTEK LD 15 LaserSystem is intended for use for incision, excision, vaporization, ablation, coagulation in oral soft tissue, for removal of diseased or inflamed soft tissue in the periodontal pocket and to perform pulpotomy and pulpotomy as adjunct to root canal therapy.
Pulpotomy and pulpotomy as adjunct to rootcanal therapy - Endodontology /
Removal of diseased or inflamed soft tissue in the periodontal - Periodontology / pocket ( sulcular debridement )
- Soft Tissue
Gingivectomy, Gingival incision and excisionTissue retraction for impressions, Frenectomy, Treatment of aphtous ulcers, Excisional and incisional biopsies, Incising and draining of abscesses, Exposure of unerupted teeth, Hemostasis
Device Description
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K Number
K974057Device Name
DENTEK LD 15 LASERSYSTEM
Manufacturer
DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H.
Date Cleared
1998-04-21
(176 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended Uses: The DENTEK LD 15 LaserSystem is intended for use for incision, excision, vaporization, ablation and coagulation and in oral soft tissue
Indications for Use:
- Soft Tissue
. gingivectomy
. gingival incisions and excisions
. tissue retraction for impressions
frenectomy
. treatment of aphthous ulcers
. excisional and incisional biopsies
. incising and draining of abscesses
. exposure of unerupted teeth
. hemostasis
Device Description
Not Found
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