510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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3M Imtec

St. Paul, MN, US

3M Imtec appears in FDA device records in St. Paul, MN. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 3 recalls for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
3
Registered establishments
0

FDA records under these names

2 names

FDA records resolved to 3M Imtec carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • IMTEC Corporationrecall
  • IMTEC IMAGING L.L.C.recall

510(k) clearance history

FDA records hold 1 510(k) clearance for 3M Imtec in 2010.

Clearances by year, as a table
510(k) clearance decisions for 3M Imtec, by decision year
YearClearances
20101
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K094064ILUMA VISION MODEL VERSION 2.2LLZSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1703-2010S1813OB 1.8X13mm Sendax MDI Mini Dental Implant O-Ball Prosthetic HeadProduct has Incorrect size Labeling. Actual length is 13mm. One label is correct, and one states 10mm.Terminated
Z-2239-2009ILUMAVision Software, version 2.1.0 Picture Archiving and Communication system Product used as a tool for the pre-surgical planning of the placement of dental implants and pre-surgical fabrication of stents to aid in dental implant insertion. In addition, it is used for diagnostics and treatment planning in orthodontic, ENT and similar applications.Under certain circumstances, software Version 2.1.0 has potential for incorrect data imaging and patient identification.Terminated
Z-1997-2009MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant. The product is used as a endosseous dental implant.Size printed on product packaging does not match size of enclosed product.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain