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Combi Long Abutment CAB4555L

by Dentium USA

Combi Long Abutment CAB4555L is a Class II device made by Dentium USA, cleared under FDA 510(k) K052957 on 27 Jul 2006 and listed in FDA GUDID since 29 Aug 2016 (UDI-DI D755CAB4555L0), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K052957

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD755CAB4555L0 UDI-DI Date29 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK052957 Date27 Jul 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K052957 decided 27 Jul 2006 Active
  • FDA GUDID UDI-DI D755CAB4555L0 listed 29 Aug 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K052957
  2. Listed FDA GUDID D755CAB4555L0

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Combi Long Abutment
Generic name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
CAB4555L
Primary DI / UDI-DI
D755CAB4555L0
510(k) Number
FDA product code
NHA
GMDN term
Dental implant suprastructure, permanent, preformed
Device class
Class II
Regulation number
872.3630
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional
Size
Outer Diameter — 4.5 Millimeter
Length — 17.1 Millimeter

Similar devices in this category

Other devices filed under Dental implant suprastructure, permanent, preformed.

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Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (8, all answered No)