FDA.report

Implant Prosthetics

Primary DI
00842092123799
Brand
Implant Prosthetics
Company
PREAT CORPORATION
Model
9000700
Catalog number
9000700
Device description
Nobel Tri-Lobe 6.0 Analog
Published
2022-06-28
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

Contact Domains

Product Codes

CodeName
DZADRILL, DENTAL, INTRAORAL
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
DZADrill, Dental, IntraoralDental1
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842092181164PackageGS110In Commercial Distribution
00842092181171PackageGS125In Commercial Distribution
00842092123799PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092181164008420921811648420921811640842092181164
00842092181171008420921811718420921811710842092181171
00842092123799008420921237998420921237990842092123799

GMDN Terms

TermDefinition
Dental laboratory mandrelA round shaft of substantial dimensions designed to be used in the dental laboratory to hold (locked into place) a rotating device, e.g., a grinding or polishing wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing; connectors and rotating endpieces may be included with the device. The mandrel will be placed into a laboratory dental handpiece or lathe that will rotate at high speed. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800) 232-7732lauren@preat.com
+1(800) 232-7732info@preat.com
+1 (800) 232-7732info@preat.com

Regulatory Flags

DUNS number
054875224
Device count
1
DM exempt
false
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
false
Sterilization required before use
true

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00842092186640Equator214299221429922026-02-06
00842092186657Equator214299621429962026-02-05
00842092186664Equator214200321420032026-02-05
00842092184028Preat7101067101062025-12-22
00842092184073Preat7100457100452025-12-22
00842092184080Preat7100467100462025-12-22
00842092184134Preat7100557100552025-12-22
00842092184141Preat7100567100562025-12-22
00842092184301Preat7100107100102025-12-22
00842092184370Preat7100207100202025-12-22
00842092184660Preat7100857100852025-12-22
00842092184677Preat7100867100862025-12-22
00842092184721Preat7100957100952025-12-22
00842092184738Preat7100967100962025-12-22
00842092184745Preat7101517101512025-12-22
00842092184783Preat7101557101552025-12-22
00842092184790Preat7101567101562025-12-22
00842092184844Preat7101457101452025-12-22

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