FDA.reportPublic FDA data

ZA-55 Scaler B.F. A-dec

Primary DI
J021100355321
Brand
ZA-55 Scaler B.F. A-dec
Company
W & H Dentalwerk Bürmoos GmbH
Model
10035532
Device description
Air Scaler
Published
2016-09-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ELCScaler, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELCScaler, UltrasonicDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J021100355321PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pneumatic dental scaling/debridement systemAn assembly of devices designed to use compressed air to generate a vibrating action at its point of patient contact to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. It typically consists of a handpiece which converts pneumatic energy into sonic vibrational energy (e.g., at a frequency of 6 kHz); appropriate connection tubing; and a self-locking, removable tip(s); tip selection typically affects the intended application (endodontic vs periodontal).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
300238441
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J021301790001EA-53 electric motor (A-dec)301790002023-07-11
J021304950011Foot control S-NW3304950012026-06-23
J021304970001Foot control S-N3304970002026-06-23
J021305040001Implantmed Plus II (SI-2100)305040002026-06-23
J021305050001Implantmed Plus II (SI-2101)305050002026-06-23
J021305060001Implantmed Plus II (SI-2102)305060002026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)305070002026-06-23
J021122275011EB-75 Endea 16:1122275012018-08-31
J021122279011EB-79 Endea 2:1122279012018-08-31
J021300010031TG-98 L Megagen300010032022-03-30
J021300040031TG-97 L Megagen300040032022-03-30
J021301040001AM-25 A BC Air Motor301040002023-07-11
J021301120001AM-25 BC Air Motor301120002023-07-11
J021302120011WG-57 LT302120012023-07-11
J021302180001WK-66 LT S302180002019-09-10
J021303100021Assistina Twin MB-302303100022022-11-29
J021303980021MB-301 Assistina ONE303980022022-08-24
J021078122001Tip Set: 1E, 2E, 3E, 4E, 5E, 6E078122002023-08-14
J021058492011Scaler Tip 4U058492012023-07-19
J021058494011Scaler Tip 1R058494012023-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979865810038JAS MotorDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810045JAS FillDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810052JAS PexDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810069JAS ActivatorDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810076JAS Charging UnitDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810083JAS Contra-AngleDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810090JAS Power SupplyDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810106JAS Activator Ultrasonic TipsDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810113JAS Fill Gutta-Percha NeedlesDENJOY DENTAL CO.,LTDELC2026-09-24
06979865810175JAS Unit Endo SystemDENJOY DENTAL CO.,LTDELC2026-09-24
07613353194963PIEZON Handpiece S5E.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353240950PIEZON Handpiece LEDE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353257743AIR-FLOW-PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353311803Instrument PI starter kitE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353318123GBT Machine Wireless PedalE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353318581AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353334833GBT Machine AIRFLOW Prophylaxis MasterE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353343408PIEZON Handpiece LEDE.M.S. Electro Medical Systems S.A.ELC2026-07-14
07613353028374PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353170318PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353170325PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353223182PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
07613353225117PIEZONE.M.S. Electro Medical Systems S.A.ELC2026-07-13
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