FDA.report

Implant Prosthetics

Primary DI
00842092124802
Brand
Implant Prosthetics
Company
PREAT CORPORATION
Model
9003753
Catalog number
9003753
Device description
Multi-Unit Guide Pin
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
00842092124802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092124802008420921248028420921248020842092124802

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

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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00842092186657Equator214299621429962026-02-05
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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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