PressCeramic 742817

GUDID 00842271157560

PressCeramic HT A1 /4

SAGEMAX BIOCERAMICS, INC

Dental implant suprastructure, permanent, preformed
Primary Device ID00842271157560
NIH Device Record Key495fea98-1cb6-48c2-86b2-6ea75f30c7f9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePressCeramic
Version Model NumberPressCeramic HT A1 /4
Catalog Number742817
Company DUNS002265727
Company NameSAGEMAX BIOCERAMICS, INC
Device Count4
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842271157560 [Unit of Use]
GS100842271164087 [Primary]

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-28
Device Publish Date2023-08-18

On-Brand Devices [PressCeramic]

00842271157676PressCeramic HT C3 /4
00842271157669PressCeramic HT C2 /4
00842271157652PressCeramic HT C1 /4
00842271157645PressCeramic HT B4 /4
00842271157638PressCeramic HT B3 /4
00842271157621PressCeramic HT B2 /4
00842271157614PressCeramic HT B1 /4
00842271157607PressCeramic HT A4 /4
00842271157591PressCeramic HT A3.5 /4
00842271157584PressCeramic HT A3 /4
00842271157577PressCeramic HT A2 /4
00842271157560PressCeramic HT A1 /4
00842271158147PressCeramic Opal 2 /4
00842271158130PressCeramic Opal 1 /4
00842271158123PressCeramic MO 4 /4
00842271158116PressCeramic MO 3 /4
00842271158109PressCeramic MO 2 /4
00842271158093PressCeramic MO 1 /4
00842271158086PressCeramic MO 0 /4
00842271158079PressCeramic LT D4 /4
00842271158062PressCeramic LT D3 /4
00842271158055PressCeramic LT D2 /4
00842271158048PressCeramic LT C4 /4
00842271158031PressCeramic LT C3 /4
00842271158024PressCeramic LT C2 /4
00842271158017PressCeramic LT C1 /4
00842271158000PressCeramic LT B4 /4
00842271157997PressCeramic LT B3 /4
00842271157980PressCeramic LT B2 /4
00842271157973PressCeramic LT B1 /4
00842271157966PressCeramic LT A4 /4
00842271157959PressCeramic LT A3.5 /4
00842271157942PressCeramic LT A3 /4
00842271157928PressCeramic LT A1 /4
00842271157911PressCeramic LT BL4 /4
00842271157904PressCeramic LT BL3 /4
00842271157898PressCeramic LT BL2 /4
00842271157881PressCeramic LT BL1 /4
00842271157874PressCeramic MT BL4 /4
00842271157867PressCeramic MT BL3 /4
00842271157850PressCeramic MT BL2 /4
00842271157843PressCeramic MT D2 /4
00842271157836PressCeramic MT C2 /4
00842271157829PressCeramic MT C1 /4
00842271157812PressCeramic MT B2 /4
00842271157805PressCeramic MT B1 /4
00842271157799PressCeramic MT A3.5 /4
00842271157782PressCeramic MT A3 /4
00842271157768PressCeramic MT A1 /4
00842271157751PressCeramic HT BL4 /4

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