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Breeze N97E

by Kerr Corporation

Ref N97E

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00814978022588 Basic UDI-DI 00814978022588UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00814978022588 UDI-DI Date1 Aug 2016ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Breeze Self Adhesive Resin Cement EUDAMED
Breeze GUDID
Generic Name
Dental composite resin
Device Name
Breeze – Self-Adhesive Resin cement Opaque White syringe (Pentron)
Model / Reference
N97E
Description
Self-Adhesive Resin Cement; Syringe; Opaceous White
Primary DI / UDI-DI
00814978022588
Basic UDI-DI
B-00814978022588
FDA Product Code
EMA
EMDN Code
Q0101010201 Dental base cements
GMDN Term
Dental composite resin
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3275
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 4 Milliliter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Dental composite resin

Other devices from Kerr Corporation

See all devices from Kerr Corporation →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No