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Imp. Zygomatic MT16° Ø4.0x30mm Ilmz 4030E

by S.I.N. - Sistema DE Implante Nacional S.A. GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07899995244918 UDI-DIDate1 Aug 2024ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Imp. Zygomatic MT16° Ø4.0x30mm
Generic Name
Screw endosteal dental implant, one-piece
Model / Ref / Catalog
ILMZ 4030E
Primary DI / UDI-DI
07899995244918
510(k) Number
FDA Product Code
DZE
GMDN Term
Screw endosteal dental implant, one-piece
Device Class
Class II
Regulation Number
872.3640
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Related devices

Category: Screw endosteal dental implant, one-piece

Cleared under the same submission (K231127)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No