FDA.report

ESTHETIC PLUS

Primary DI
07897990310003
Brand
ESTHETIC PLUS
Company
TDV DENTAL LTDA
Model
0005030006
Catalog number
0005030006
Device description
Esthetic Plus Soft + Hard - 2 Instruments + 8 Tips (PT/ES/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

Related Records

Product Codes

CodeName
EJBHandle, Instrument, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EJBHandle, Instrument, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07897990310003PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07897990310003078979903100037897990310003

GMDN Terms

TermDefinition
Dental spatula, reusableA hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device.

Sterilization Methods

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 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 DIBrandCompanyProduct codePublished
G149TBSB71050TBS BASICSACME ENTERPRISE.EJB2026-05-22
G149TBSB71060TBS BASICSACME ENTERPRISE.EJB2026-05-22
G149TBSB71070TBS BASICSACME ENTERPRISE.EJB2026-05-22
G149TBSB71080TBS BASICSACME ENTERPRISE.EJB2026-05-22
00348783010206Premier Mirror HandlesPREMIER DENTAL PRODUCTS COMPANYEJB2026-03-17
G1493807306TBS DentalACME ENTERPRISE.EJB2026-03-02
00841013120459Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
00841013120466Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EJB2026-01-06
30371347019668Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019675Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019682Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
30371347019699Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017724Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00371347017748Advance Dental ProductsThe Atlanta Dental Supply CompanyEJB2025-11-18
00883205032164Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-21
00883205032157Slide PackerULTRADENT PRODUCTS, INC.EJB2025-08-19
08806343925183ever KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925213TAPER KITShinhung MST Co., Ltd.EJB2025-07-28
08806343925220GUIDE KITShinhung MST Co., Ltd.EJB2025-07-28
08057639710567Specialist OrganizerMC BIO SRLEJB2025-06-23
08057639710574Tip with Indexable StopMC BIO SRLEJB2025-06-23
08057639710598Offset Tip SPMC BIO SRLEJB2025-06-23
08057639710604Long Tip SPMC BIO SRLEJB2025-06-23
08057639710628GBR MODULAR SETMC BIO SRLEJB2025-06-23
08057639712066Handle - Straight MDFMC BIO SRLEJB2025-06-23
08057639712073Handle - Straight - ErgalMC BIO SRLEJB2025-06-23
08057639712080Handle - Straight SP (TiN)MC BIO SRLEJB2025-06-23
08057639712097Handle - Asym. - ErgalMC BIO SRLEJB2025-06-23
08057639712103Handle - Asym. - SP (TiN)MC BIO SRLEJB2025-06-23
08057639712110Handle - Asym. - TitaniumMC BIO SRLEJB2025-06-23