FDA.reportPublic FDA data

AIR-FLOW

Primary DI
07613353077297
Brand
AIR-FLOW
Company
E.M.S. Electro Medical Systems S.A.
Model
a
Catalog number
FT-177#HF/A/001
Device description
AIR-FLOW S1
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K900709000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K900709000AIR FLOW SIIElectro Medical Systems (Ems Sa)1990-04-18ELC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613353077297PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613353077297076133530772977613353077297

GMDN Terms#

Term, Definition table
TermDefinition
Chairside dental abrasive air jet systemAn assembly of devices that comprises a dental abrasive air jet system used to direct a concentrated jet of air combined with an abrasive powder, together with water for cooling, to the surface of the patient's tooth/teeth. It typically consists of a control unit, a dedicated intraoral handpiece and a foot switch that enables the dentist to control the abrasion process; some types are known as a sandblaster. It has a variety of applications such as, the removal of plaque and stains, cleaning fissures, the preparation of the tooth surface prior to bonding, the cleaning of orthodontic appliances (bands, brackets), the removal of adhesive residue and the cleaning of implants prior to loading.

Contacts#

Phone, Email table
PhoneEmail
+41229944700udi@ems-ch.com

Regulatory Flags#

DUNS number
481233849
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613353343965AIR-FLOWFS-477/USFS-477/US/MX2025-07-07
07613353336790Instrument PI starter kitFS-295#FS-295#2025-04-23
07613353313500GBT Machine StationDW-1002026-02-16
07613353337476PIEZONDS-083A/B2025-06-10
07613353337490PIEZONDS-084A/B2025-06-10
07613353179557PIEZONDS-001A/T2019-12-13
07613353183493PIEZONDS-011A/T2019-12-13
07613353183486PIEZONDS-011A/A2019-12-11
07613353183523PIEZONDS-016A/A2019-12-11
07613353183769PIEZONDS-083A/A2019-12-11
07613353183776PIEZONDS-083A/T2019-12-11
07613353183783PIEZONDS-084A/A2019-12-11
07613353183790PIEZONDS-084A/T2019-12-11
07613353179199PIEZONDS-001A/A2019-12-10
07613353198312AIR-FLOWDT-476A/US2020-11-02
07613353207045AIR-FLOWEL-308#YC/0012020-11-19
07613353257224AIR-FLOW-PIEZONFT-229Default2025-10-20
07613353257323AIR-FLOW-PIEZONFT-229-2B-V022025-10-20
07613353257576AIR-FLOW-PIEZONFT-229-2B-3022025-10-20
07613353257866AIR-FLOWFT-230-2B-V022025-10-20

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