FDA.reportPublic FDA data

Sphero Attachments

Primary DI
00842092108512
Brand
Sphero Attachments
Company
Preat Corporation
Model
0800512
Catalog number
0800512
Device description
Sphero Flex Post Medium 7.50mm
Published
2016-09-16
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DZEImplant, Endosseous, Root-Form

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZEImplant, Endosseous, Root-FormDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842092108512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842092108512008420921085128420921085120842092108512

GMDN Terms#

Term, Definition table
TermDefinition
Partial dentureA custom-made, removeable, artificial replacement for one or more, but not all, teeth in the lower or upper jaw (mandible or maxilla) in a partially edentulous patient. It typically includes clasps of metal or plastic that clip onto remaining teeth for retention and stabilization. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)]. Also known as a removable partial denture (RPD).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 232-7732info@preat.com

Regulatory Flags#

DUNS number
117776048
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842092184301Preat7100107100102025-12-22
00842092184370Preat7100207100202025-12-22
00842092185391Preat7105407105402025-12-22
00842092185414Preat7105427105422025-12-22
00842092185421Preat7105437105432025-12-22
00842092185438Preat7105447105442025-12-22
00842092185445Preat7105457105452025-12-22
00842092185452Preat7105507105502025-12-22
00842092184257Preat7101717101712025-07-24
00842092184394Preat7100227100222025-07-24
00842092184400Preat7100237100232025-07-24
00842092184417Preat7100247100242025-07-24
00842092184424Preat7100257100252025-07-24
00842092184448Preat7100327100322025-07-24
00842092184455Preat7100337100332025-07-24
00842092184462Preat7100347100342025-07-24
00842092184516Preat7102217102212025-07-24
00842092184561Preat7107117107112025-07-24
00842092184578Preat7107127107122025-07-24
00842092184585Preat7107137107132025-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260516878418SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878425SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878432SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878449SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878456SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878715SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878722SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878739SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878746SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516878753SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879613SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879620SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879637SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879644SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879651SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879668SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879675SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879682SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879699SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879705SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879712SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879729SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879736SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879743SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879750SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879767SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879774SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879781SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879798SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04
04260516879804SIC invent Dental Implant SystemsSIC invent AGDZE2026-09-04