FDA.reportPublic FDA data

MOUNTED STONES

Primary DI
D772ATI36085W30
Brand
MOUNTED STONES
Company
AMERICAN TOOTH INDUSTRIES
Model
08-36085 W3
Device description
72 MOUNTED STONES WHITE
Published
2023-10-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
D772ATI36085W30PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
161532999
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D722ATI199925560CARBIDE BURRS016-19992-5562023-11-17
D772ATI1999220CARBIDE BURRS016-19992-22023-11-17
D772ATI1999230CARBIDE BURRS016-19992-32023-11-17
D772ATI199923350CARBIDE BURRS016-19992-33-52023-11-17
D772ATI19992340CARBIDE BURRS016-19992-342023-11-17
D772ATI19992350CARBIDE BURRS016-19992-352023-11-17
D772ATI19992360CARBIDE BURRS016-19992-362023-11-17
D772ATI19992370CARBIDE BURRS016-19992-372023-11-17
D772ATI19992380CARBIDE BURRS016-19992-382023-11-17
D772ATI19992390CARBIDE BURRS016-19992-392023-11-17
D772ATI1999240CARBIDE BURRS016-19992-42023-11-17
D772ATI1999250CARBIDE BURRS016-19992-52023-11-17
D772ATI199925570CARBIDE BURRS016-19992-5572023-11-17
D772ATI199925580CARBIDE BURRS016-19992-5582023-11-17
D772ATI199925590CARBIDE BURRS016-19992-5592023-11-17
D772ATI19992560CARBIDE BURRS016-19992-562023-11-17
D772ATI199925600CARBIDE BURRS016-19992-5602023-11-17
D772ATI19992570CARBIDE BURRS016-19992-572023-11-17
D772ATI19992580CARBIDE BURRS016-19992-582023-11-17
D772ATI19992590CARBIDE BURRS016-19992-592023-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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