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510(k) Data Aggregation
K Number
K060347Device Name
B&L L-BETA, MODEL WL-B1
Manufacturer
B&L BIOTECH CO., LTD.
Date Cleared
2006-06-05
(115 days)
Product Code
EKR
Regulation Number
872.4565Why did this record match?
Product Code :
EKR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for use by professionally qualified Licensed dentists, endodontists and clinicians to heat gutta percha and to place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal.
Device Description
The B& L-Bcta(Model: WL-B1) is an electrically powered dental device used for heating gutta percha and placing the softened material in prepared root canals of teeth during root canal therapy. This model has a temperature memory controls. The user gently squeezes the trigger to express the desired amount of gutta percha in to the root canal through a soft silver applicator needle as the predicate, Obtura Heated Gutta Percha System(K042828)
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K Number
K042828Device Name
OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700
Manufacturer
YOUNG O/S LLC
Date Cleared
2004-12-01
(50 days)
Product Code
EKR
Regulation Number
872.4565Why did this record match?
Product Code :
EKR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Obtura is intended for used by professionally qualified dentists, endodontists and dental clinicians to heat Gutta Percha and to place it into the previously prepared root canals of human teeth, in order to provide a quick and complete obturation of the canal.
Device Description
The device is an electrically powered dental device used for heating gutta percha and placing the softened material in prepared root canals of teeth during rot canal therapy. The Obtura is an established device that has been marketed for over 20 years with an estimated 30,000 in use worldwide. This model incorporates interchangeable handpieces, membrane switches and temperature memory controls. The user gently squeezes the trigger to express the desired amount of gutta percha in to the root canal through a soft silver applicator needle as the predicate Heated Gutta Percha System, #K832654.
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K Number
K031664Device Name
ELEMENTS OBTURATION UNIT
Manufacturer
SYBRON ENDO/ANALYTIC
Date Cleared
2004-04-28
(335 days)
Product Code
EKR
Regulation Number
872.4565Why did this record match?
Product Code :
EKR
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Elements Obturation Unit is intended to be used in Dentistry to:
1. Provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus,
2. For tissue cauterization and coagulation, and
3. To backfill and downpack gutta percha during Endodontic root canal treatment.
4. When in Extruder mode, the Elements Obturation Unit is used only to backfill gutta percha during root canal obturation.
Device Description
The device is an AC powered endodontic unit designed to be used in either of two modes, a) the System B Mode to 1) downpack and backfill gutta percha during root canal obturation, 2) test tooth response to thermal stimulus (Hot Pulp Test) and 3) for tissue cautery, and b) the Extruder Mode to backfill gutta percha during root canal obturation. The unit has an LCD screen with membrane switch controls. When using the unit in the System B Mode, the user may select the appropriate switch to downpack, backfill, cauterize or hot pulp test. While the temperature has a preset value with each of the four selections, it can also be adjusted using the temperature adjust button. In the Extruder Mode, the user may select the gutta percha type (alpha or beta), speed of extrusion (high or low), alarm sound setting and volume/mode, The endodontic obturation unit is controlled by a microprocessor that is designed to support a network style communication allowing information to be shared between endodontic devices. The System B and Extrusion hand pieces are completely removable and autoclavable.
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