Esbond S1 101-5006

by Spident Co., Ltd.

Esbond S1 101-5006 is a dental composite resin (FDA Class II; FDA product code EBF, Material, Tooth Shade, Resin) made by Spident Co., Ltd., cleared under FDA 510(k) K092572 on 26 Aug 2009 and listed in FDA GUDID since 21 Aug 2018 (UDI-DI 08809262959949), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number08809262959949 UDI-DI	Date21 Aug 2018Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK092572	Date26 Aug 2009Decided	StatusActive

Official records

AccessGUDID record UDI-DI 08809262959949
FDA 510(k) database 510(k) number K092572

Across registries

2 registries list this device

FDA 510(k) K092572 decided 26 Aug 2009 Active
FDA GUDID UDI-DI 08809262959949 listed 21 Aug 2018 Listed

Timeline

2 dated events

26 Aug 2009 Cleared FDA 510(k) K092572
21 Aug 2018 Listed FDA GUDID 08809262959949

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Esbond S1
Generic name: Dental composite resin
Model / Ref / Catalog: 101-5006

Primary DI / UDI-DI: 08809262959949
510(k) Number: K092572
FDA product code: EBF
GMDN term: Dental composite resin

Device class: Class II
Regulation number: 872.3690
GUDID distribution status: In Commercial Distribution

Other devices from Spident Co., Ltd.

See all devices from Spident Co., Ltd. →

Properties

Prescription use
Lot / batch number
Expiration date

Other properties (12, all answered No)