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510(k) Data Aggregation
K Number
K021508Device Name
OPUSDUO EC DENTAL LASER SYSTEM
Manufacturer
OPUSDENT LTD.
Date Cleared
2002-08-07
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
OPUSDENT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OpusDuo EC Dental Laser System is intended to aid during dental procedures performed either in hard or soft oral tissue.
The Er: YAG laser component is indicated for caries removal, cavity preparation, enamel etching and the, incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacia! surgery and dentistry. These include the following:
Soft tissue and periodontal indications: Excisional and incisional biopsies; Exposure of unerupted teeth; Incision and drainage of abscesses; Gingival incision and excision; Gingivoplasties; Gingivectomies, Gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias; Gingival troughing for crown impressions; Hemostasis; Implant recovery; Frenectomies and frenotomies; Fibromatosis (fibroma removal); Benign and malignant lesion removal; Operculectomy; Oral papillectomies; Reduction of gingival hypertrophy; Soft tissue crown lengthening; Preprosthetic surgery; flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasias, epulides, papilomas, fibromatoses, benign growths; Vestibuloplasty; Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
Endodontal Applications: Tooth preparation to obtain access to root canal; Pulpotomy; Pulp extirpation; Pul potomy as an adjunct to root canal therapy; Root canal debridement and cleaning; Root canal preparation including enlargement
The CO2 laser component is indicated for periodontal procedures such as removal of diseased or inflamed soft tissue in the periodontal pocket (sulcular debridement) and vaporization, excision coagulation and ablation of oral soft tissue in procedures such as gingivectorny; frenum release; removal of soft tissue, cysts and tumors.
Device Description
The OpusDuo EC is a model of the Opus 20 Dental Laser System, which is intended to aid during dental procedures performed either in hard or soft oral tissue. This is a dual laser system incorporating an Er:YAG laser and a CO2 laser. The system is operating at a wavelength of 2.94 microns and 10.6 microns respectively. The Er: YAG laser delivers to the tissue pulses with energies up to 1 joule per pulse and power up to 12 Watts. The CO2 laser delivers to the tissue power in continuous mode (CW) up to 10 Watts and pulses (SP) up to 6 Watts.
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K Number
K014100Device Name
OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND
Manufacturer
OPUSDENT LTD.
Date Cleared
2002-01-08
(26 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
OPUSDENT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OpuDuo Dental Laser System is intended to aid during dental procedures performed either in hard or soft oral tissue.
The Er: YAG laser component is indicated for caries removal, cavity preparation, and enamel etching.
The CO2 laser component is indicated for vaporization, excision and coagulation of oral soft tissue in procedures such as gingivectomy; frenum release; removal of soft tissue, cysts and tumors.
Device Description
The Opus Spectrum c is a model of the Opus 20 Dental Laser System which is intended to aid during dental procedure performed either in hard or soft oral tissue. This is a dual laser system incorporating an Er: Y AG laser and a CO2 laser. The system is operating at a wavelength of 2.94 microns and 10.6 microns respectively. The Er:YAG laser delivers to the tissue pulses with energies up to 1 joule per pulse and power up to 12 Watts. . The CO2 laser delivers to the tissue power in continuous mode (CW) up to 10 Watts and pulses (SP) up to 6 Watts.
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K Number
K011769Device Name
OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND
Manufacturer
OPUSDENT LTD.
Date Cleared
2001-08-30
(84 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
OPUSDENT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Opus 10TM 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 Opus 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 periodental pocket)
Oral Soft Tissue Surgery
- Biopsy
- Operculectomy
- Gingivectomy
- Gingivoplasty
- Papillectomy
- Lesion (tumor) removal
- Leukoplakia
- Treatment of aphthous ulcers
- Fibroma removal
- Frenectomies and frenotomies
- Tissue retraction for impressions
- Incising and draining of abscesses
- Exposure of unerupted teeth
Device Description
The Opus 10TM Dental Diode Laser is designed to perform several medical procedures in the oral soft tissue and to perform laser assisted aesthetic tooth whitening procedures.
A Gallium Aluminum Arsenide (GaAIAs) solid state laser diode provides optical energy to oral soft tissues.
A fiber optic held by an handpiece delivers the Opus 10™ laser energy. A visible light emitted from the handpiece's distal end targets the area of treatment. The optical power output and pulse may be adjusted to specific use requirements.
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K Number
K002899Device Name
OPUS 20, MODEL 1ST
Manufacturer
OPUSDENT LTD.
Date Cleared
2000-12-12
(85 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
OPUSDENT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000990Device Name
OPUS 10 DENTAL DIODE LASER
Manufacturer
OPUSDENT LTD.
Date Cleared
2000-06-23
(87 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
OPUSDENT LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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