FDA.report

Perfit ZR

Primary DI
08800099973702
Brand
Perfit ZR
Company
Vatech mcis Co., Ltd
Model
NU 25 BL1S W
Published
2025-04-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EIFAccessories, Retractor, Dental

Product Code Classifications

CodeDeviceSpecialtyClass
EIFAccessories, Retractor, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08800099973702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08800099973702088000999737028800099973702

GMDN Terms

TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods

Method

Regulatory Flags

DUNS number
688284886
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
08800099963765Perfit ZRNU 10 BL1 W2025-04-07
08800099963772Perfit ZRNU 10 BL2 W2025-04-07
08800099963789Perfit ZRNU 10 BL3 W2025-04-07
08800099963796Perfit ZRNU 10 BL4 W2025-04-07
08800099963802Perfit ZRNU 12 BL1 W2025-04-07
08800099963819Perfit ZRNU 12 BL2 W2025-04-07
08800099963826Perfit ZRNU 12 BL3 W2025-04-07
08800099963833Perfit ZRNU 12 BL4 W2025-04-07
08800099963840Perfit ZRNU 14 BL1 W2025-04-07
08800099963857Perfit ZRNU 14 BL2 W2025-04-07
08800099963864Perfit ZRNU 14 BL3 W2025-04-07
08800099963871Perfit ZRNU 14 BL4 W2025-04-07
08800099963888Perfit ZRNU 16 BL1 W2025-04-07
08800099963895Perfit ZRNU 16 BL2 W2025-04-07
08800099963901Perfit ZRNU 16 BL3 W2025-04-07
08800099963918Perfit ZRNU 16 BL4 W2025-04-07
08800099963925Perfit ZRNU 18 BL1 W2025-04-07
08800099963932Perfit ZRNU 18 BL2 W2025-04-07
08800099963949Perfit ZRNU 18 BL3 W2025-04-07
08800099963956Perfit ZRNU 18 BL4 W2025-04-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04251436943836KOHLERKohler Medizintechnik GmbHEIF2026-03-12
00840479200040CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
00840479200057CHEEK RETRACTORRELIANCE ORTHODONTIC PRODUCTS INCEIF2026-02-23
00810042124875OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCEIF2026-01-28
D248938520Uni-Wedge Regular ( Orange)HAGER WORLDWIDE, INC.EIF2026-01-28
07630716617037Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616382Geistlich PanoramaDSSM AGEIF2025-09-17
07630716616399Geistlich PanoramaDSSM AGEIF2025-09-17
07630716617051Geistlich PanoramaDSSM AGEIF2025-09-17
00840456215074JMUJMU DENTAL, INCEIF2025-07-15
00860013984601TissuePro™ Distal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984618TissuePro™ Proximal Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984625TissuePro™ Single Sleeve, MN RetractorArmor Dental Corp.EIF2025-05-12
00860013984632TissuePro™ Distal Sleeve, MN Retractor Single-UseArmor Dental Corp.EIF2025-05-12
08800099963765Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963772Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963789Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963796Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963802Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963819Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963826Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963833Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963840Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963857Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963864Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963871Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963888Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963895Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963901Perfit ZRVatech mcis Co., LtdEIF2025-04-07
08800099963918Perfit ZRVatech mcis Co., LtdEIF2025-04-07