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NobelZygoma™ PureSet Tray

EUDAMEDFDA UDIFDA 510(k)

Class I (EU MDR)

Ref PUR1000

by Nobel Biocare AB

Identity

Trade Name
NobelZygoma™ PureSet Tray EUDAMED
PureSet™ FDA UDI
Generic Name
Instrument tray, reusable FDA UDI
Device Name
Sterilization trays and plates EUDAMED
NobelZygoma™ PureSet Tray FDA UDI
Model / Reference
PUR1000 EUDAMEDFDA UDI
Description
NobelZygoma™ PureSet Tray FDA UDI

Identifiers

Catalog Number
PUR1000 FDA UDI
Primary DI / UDI-DI
07332747198188 EUDAMEDFDA UDI
Basic UDI-DI
73327470000001436Z EUDAMED
Direct Marketing DI
07332747198188 EUDAMED
510(k) Number
K231219 FDA UDI
FDA Product Code
KCT FDA UDI
EMDN Code
S0199 DEVICES FOR STERILISATION AND PACKAGING (EXCLUDING CAT. D - Z) - OTHER EUDAMED
GMDN Term
Instrument tray, reusable FDA UDI

Classification

Device Class
Class I EUDAMED
Class II FDA UDI
Regulation Number
880.6850 FDA UDI
Market of Registration
Sweden EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Height — 58.900 Millimeter FDA UDI
Length — 276.100 Millimeter FDA UDI
Width — 176.000 Millimeter FDA UDI

NobelZygoma™ PureSet Tray by Nobel Biocare AB — Class I — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Nobel Biocare AB
EUDAMED SRN
SE-MF-000000009

Sources (3)

  • EUDAMED d80ffba0-663b-42cc-ad9f-bd4aa9a9f4a4 61 fields · synced Jul 21, 2026
  • FDA UDI 1ba8ba18-43dd-474e-a35f-012dbe7dd9c4 38 fields · synced May 30, 2026
  • FDA 510(k) K181075 1 fields · synced May 18, 2026