FDA.reportPublic FDA data

Engler 25K Series S-1

Primary DI
00636266958702
Brand
Engler 25K Series S-1
Company
ENGLER ENGINEERING CORPORATION
Model
S 1
Catalog number
A70101
Device description
Dental 25 K insert with pointed tip
Published
2018-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122748000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122748000ENGLER 25K SERIES ULTRASONIC INSERTSEngler Engineering Corp.2013-06-11ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00636266958702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00636266958702006362669587026362669587020636266958702

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.

Sterilization Methods#

Method table
Method
Liquid Chemical;Dry Heat Sterilization

Regulatory Flags#

DUNS number
002965168
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
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
00862872000324Sonus M4 M 4133-12042021-05-04
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
00636266958719Engler 25K Series S-4S-4A701042018-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J021304950011Foot control S-NW3W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021304970001Foot control S-N3W & H Dentalwerk Bürmoos GmbHELC2026-06-23
J021305040001Implantmed Plus II (SI-2100)W & H Dentalwerk Bürmoos GmbHELC2026-06-23
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
04560264548459Powder Handpiece(For Prophy use)NAKANISHI INC.ELC2026-06-11
04560264548473Powder Handpiece(For Perio use)NAKANISHI INC.ELC2026-06-11
04560264579538CLM Bottole SetNAKANISHI INC.ELC2026-06-11
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04589551391219Perio Kit2NAKANISHI INC.ELC2026-06-11
04589551395095Varios Combi Pro2 Basic SetNAKANISHI INC.ELC2026-06-11
04589551395323CLM Module SetNAKANISHI INC.ELC2026-06-11
04589551395347Water Bottle KitNAKANISHI INC.ELC2026-06-11
04589551395439FC-83NAKANISHI INC.ELC2026-06-11
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07613353335113PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-21
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