FDA.reportPublic FDA data

SCALEX

Primary DI
00858466005110
Brand
SCALEX
Company
DENTAMERICA, INC.
Model
830
Device description
Ultrasonic Scaler
Published
2016-10-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954820000SCALEX 800Dentamerica1996-01-18ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858466005110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858466005110008584660051108584660051100858466005110

GMDN Terms#

Term, Definition table
TermDefinition
Dental delivery system instrument unit, electricA mains electricity (AC-powered) device designed to make available the necessary instruments/equipment and power to deliver dental treatment to a patient. It consists of a platform for the display of a selection of powered dental instruments (e.g., motor handpiece, scaler, suction, air/water spray), sometimes with a control panel for setting various operating parameters; it may be portable or mounted. The device is commonly referred to as a dental unit or dental operative unit and is intended to be operated by a healthcare professional in a medical facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
174436360
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850461008196APIXIA108102026-04-22
00850461008202APIXIA108112026-04-22
00850461008219APIXIA108122026-04-22
00850461008226APIXIA108132026-04-22
00850461008233APIXIA108142026-04-22
00850461008240APIXIA108552026-04-22
00858466005219SCALEX980P2026-04-22
00858466005257ENDOMAX178BRT2026-04-22
00850461008042APIXIA DIGIREX108US2026-04-21
00850461008097DIGIREX105MX2026-04-21
00858466005004POLYBITE8852026-04-21
00858466005011POLYBITE8862026-04-21
00858466005028POLYBITE8872026-04-21
00858466005035POLYBITE8882026-04-21
00858466005042POLYBITE8892026-04-21
00858466005059DENTAMERICA4012026-04-21
00858466005066DENTAMERICA4022026-04-21
00858466005073DENTAMERICA4032026-04-21
00858466005080DENTAMERICA4152026-04-21
00858466005097DENTAMERICA4162026-04-21

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
04560264579569CLM HolderNAKANISHI INC.ELC2026-06-11
04589551391202Prophy Kit2NAKANISHI INC.ELC2026-06-11
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
04589551386758VA-SG-TIP HOLDERNAKANISHI INC.ELC2026-04-08
07630392912617BioSonicDent4You AGELC2026-04-06
07630392912624BioSonicDent4You AGELC2026-04-06
07630392912631BioSonicDent4You AGELC2026-04-06
07630392912648BioSonicDent4You AGELC2026-04-06
07613353352356GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-02-24
07613353313500GBT Machine StationE.M.S. Electro Medical Systems S.A.ELC2026-02-16
07613353335847AIR-FLOWE.M.S. Electro Medical Systems S.A.ELC2026-02-16
D00381702011Cavitron®Dentsply ProfessionalELC2026-01-20
10889950154066PWR AirHU-FRIEDY MFG. CO., LLCELC2026-01-14
10889950154080HuFriedyGroupHU-FRIEDY MFG. CO., LLCELC2026-01-14
10889950154103HuFriedyGroupHU-FRIEDY MFG. CO., LLCELC2026-01-14
07613353335113PIEZONE.M.S. Electro Medical Systems S.A.ELC2025-10-21
07613353341404PiezonE.M.S. Electro Medical Systems S.A.ELC2025-10-21