FDA.reportPublic FDA data

VERSAPLUS MANDREL

Primary DI
07897990311857
Brand
VERSAPLUS MANDREL
Company
TDV DENTAL LTDA
Model
0010010016
Catalog number
0010010016
Device description
Versaplus Mandrel - 1 Unit (EN/FR)
Published
2025-02-28
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
EJQWheel, Polishing Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJQWheel, Polishing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07897990311857PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07897990311857078979903118577897990311857

GMDN Terms#

Term, Definition table
TermDefinition
Dental mandrelA slender, round, metal shaft designed to be used chairside to hold (locked into place) a rotating dental device, e.g., a grinding wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing. The mandrel will be placed into a dental handpiece that will rotate at high speed. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
900580358
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
false
Expiration date on label
true
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
07897990399091UNIMATRIX S000302030100030203012026-02-18
07897990399213UNIMATRIX S000302030000030203002026-02-18
07897990399220UNIMATRIX S000302030200030203022026-02-18
07897990301919METALLIC MATRIX STRIP000306000700030600072025-03-04
07897990301940METALLIC MATRIX STRIP000306001000030600102025-03-04
07897990302244ANATOMIC WEDGES000402002200040200222025-03-04
07897990302251ANATOMIC WEDGES000402002300040200232025-03-04
07897990302268ANATOMIC WEDGES000402002400040200242025-03-04
07897990302343MICROCUT MANUAL000500000700050000072025-03-04
07897990302428TRANSPARENT CROWNS000800000500080000052025-03-04
07897990302435TRANSPARENT CROWNS000800000600080000062025-03-04
07897990302442TRANSPARENT CROWNS000800000700080000072025-03-04
07897990302466TRANSPARENT CROWNS000800000900080000092025-03-04
07897990306297METALLIC MATRIX STRIP000306001800030600182025-03-04
07897990306303METALLIC MATRIX STRIP000306001900030600192025-03-04
07897990307126TRANSPARENT CROWNS000800050000080005002025-03-04
07897990307133TRANSPARENT CROWNS000800050100080005012025-03-04
07897990307140TRANSPARENT CROWNS000800050200080005022025-03-04
07897990307157TRANSPARENT CROWNS000800050300080005032025-03-04
07897990307164TRANSPARENT CROWNS000800050400080005042025-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630243636051KENDADent4You AGEJQ2025-09-17
07630243636075KENDADent4You AGEJQ2025-09-17
07630243636082KENDADent4You AGEJQ2025-09-17
07630243636105KENDADent4You AGEJQ2025-09-17
07630243636112KENDADent4You AGEJQ2025-09-17
07630243636099KENDADent4You AGEJQ2025-09-17
07630243641406KENDADent4You AGEJQ2025-09-17
07630243641413KENDADent4You AGEJQ2025-09-17
07630243636068KENDADent4You AGEJQ2025-09-17
07630243636228KENDADent4You AGEJQ2025-09-17
07630243636235KENDADent4You AGEJQ2025-09-17
07630243636242KENDADent4You AGEJQ2025-09-17
07630243636259KENDADent4You AGEJQ2025-09-17
07630243636273KENDADent4You AGEJQ2025-09-17
07630243636280KENDADent4You AGEJQ2025-09-17
07630243636266KENDADent4You AGEJQ2025-09-17
07630243641727KENDADent4You AGEJQ2025-09-17
07630243637225KENDADent4You AGEJQ2025-09-17
07630243637232KENDADent4You AGEJQ2025-09-17
07630243637249KENDADent4You AGEJQ2025-09-17
07630243637256KENDADent4You AGEJQ2025-09-17
07630243637362KENDADent4You AGEJQ2025-09-17
07630243637379KENDADent4You AGEJQ2025-09-17
07630243637386KENDADent4You AGEJQ2025-09-17
07630243637393KENDADent4You AGEJQ2025-09-17
07630243642052KENDADent4You AGEJQ2025-09-17
07630243642069KENDADent4You AGEJQ2025-09-17
07630243636709KENDADent4You AGEJQ2025-09-17
07630243636716KENDADent4You AGEJQ2025-09-17
07630243636730KENDADent4You AGEJQ2025-09-17