FDA.reportPublic FDA data

Diacomp

Primary DI
07630049994737
Brand
Diacomp
Company
Diaswiss SA
Model
192RA-0
Device description
Dental rotary polishing instrument for intraoral use
Published
2023-10-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EHJDISK, ABRASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EHJDisk, AbrasiveDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630049994737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630049994737076300499947377630049994737

GMDN Terms#

Term, Definition table
TermDefinition
Dental abrasive point, reusableA rotary endpiece designed to be attached to a dental power tool handpiece to produce an abrasive rotation typically for polishing and smoothing natural or restorative dental materials (e.g., crown) during a dental procedure. Also referred to as a polisher, it is available in various forms (e.g., conical), sizes, and materials [e.g., silicone, rubber, metal, diamond, silicon carbide, aluminium oxide]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480296552
Device count
1
DM exempt
true
Premarket 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
07630049901063Porcelain Veneer Set1VeneerSetPD2023-12-01
07630049901087Porcelain Veneer Set1PhucDangSet2023-12-01
07630049901100A-Z Modern Cavity Set1ModernCavitySe2023-12-01
07630049901391RootEX standard 0.8 (sample)935L.Set008-sam2023-12-01
07630049901407RootEX standard 011(sample)935L.Set011-sam2023-12-01
07630049901414RootEX standard 1.6 (sample)935L.Set016-sam2023-12-01
07630049901421RootEX standard 1.8 (sample)935L.Set018-sam2023-12-01
07630049901438RootEX standard 0.8 (sample)935K.Set008-sam2023-12-01
07630049901452RootEX standard 1.1 (sample)935K.Set011-sam2023-12-01
07630049901469RootEX standard 1.6 (sample)935K.Set016-sam2023-12-01
07630049901483RootEX standard 1.8 (sample)935K.Set018-sam2023-12-01
07630049901490Phuc Dang Set21PhucDangSet22023-12-01
07630049901520Hedstroem files 25mm 045 - 080, pu: 6325025.45802023-12-01
07630049901537Reamer 31mm 45 - 80, pu: 6 pcs231031.45802023-12-01
076300499018721Dr.XochipaSet Full Prep Set1Dr.XochipaSet2023-12-01
07630049902817Surgicut Set314Z164-set.0152023-12-01
07630049902824Porcelain Adjustment Kit RA K011AdjustmentKit2023-12-01
07630049950894rootEX instrument set short, pu: 2 pcs937K.Set2023-12-01
07630049950979rootEX instrument set long, pu: 2 pcs937L.Set2023-12-01
07630049951006Set FG diamonds short shank1ShortSet2023-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783011913Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-26
00348783011937Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-26
00348783011951Poli-Pro DisksPREMIER DENTAL PRODUCTS COMPANYEHJ2026-05-26
07908738730066DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-13
07908738730103DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-13
07908738730110DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-13
07908738730127DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-13
07908738730134DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-13
07908738730073DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-10
07908738730080DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-10
07908738730097DENFINITY3R - INDUSTRIA E COMERCIO EIRELIEHJ2026-03-10
D8120149280BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455440BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455480BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455520BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455560BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455600BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455640BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455680BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455720BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455761BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
D8120455801BUSCH®, BNA®BUSCH & CO. GmbH & Co. KGEHJ2025-12-15
00883205031501JiffyULTRADENT PRODUCTS, INC.EHJ2025-09-19
07615208472707OptraGlossIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2025-05-20
07615208292824OptraGlossIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2025-05-20
07615208471199Politip P / Politip FIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2025-05-20
07615208471182Politip P / Politip FIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2025-05-20
07615208471175Politip P / Politip FIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2025-05-20
07615208471168Politip P / Politip FIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2025-05-20
07615208471151Politip P / Politip FIVOCLAR VIVADENT AKTIENGESELLSCHAFTEHJ2025-05-20