FDA.reportPublic FDA data

Sonus M4

Primary DI
00862872000324
Brand
Sonus M4
Company
ENGLER ENGINEERING CORPORATION
Model
M 4
Catalog number
133-1204
Device description
Dental scaling tip - broad spatula style to screw into Engler insert A47030
Published
2021-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K811396000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K811396000SONUS VCalifornia Technics, Inc.1981-06-26ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00862872000324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00862872000324008628720003248628720003240862872000324

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic dental scaling/debridement system handpiece tip, periodontalAn insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.9Inch
Width0.25Inch

Sterilization Methods#

Method table
Method
Dry Heat Sterilization

Regulatory Flags#

DUNS number
002965168
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00862872000300SonusM 1133-12012021-05-04
00862872000317SonusM 2133-12022021-05-04
00862872000331Sonus Stack (Insert)A47030A470302021-05-04
00862872000348Sonus Nose Cone806-1105806-11052021-05-04
00862872000355SONUS VSonus VA520002021-05-04
00862872000362Engler 25K SeriesS 1A701012021-05-04
00862872000379Engler 25K SeriesS 4A701042021-05-04
00636266957262SONUS V SCALERSonus VA520002018-07-16
00636266958351Sonus M 2 TipM 2133-12022018-07-16
00636266958368Sonus M 3 TipM 3133-12032018-07-16
00636266958306Sonus StackA47030A470302018-07-09
00636266958337Sonus Nose Cone806-1105806-11052018-07-09
00636266958344Sonus M 1 TipM 1133-12012018-07-09
00636266958375Sonus M 4 TipM 4133-12042018-07-09
00636266958702Engler 25K Series S-1S 1A701012018-07-09
00636266958719Engler 25K Series S-4S-4A701042018-07-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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J021305050001Implantmed Plus II (SI-2101)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305060001Implantmed Plus II (SI-2102)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
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