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Rainbow Block

by GENOSS CO., Ltd.

510(k) K092513

Rainbow Block is a Class II device made by GENOSS CO., Ltd., cleared under FDA 510(k) K092513 on 9 Oct 2009, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK092513 Date9 Oct 2009ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
EIH
Device class
Class II
Regulation
21 CFR Part 872.6660
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K092513

36 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K092513
UDI-DISize and differences
rainbow block CADM01
Genoss
CADM01 / CADM0108809324767376
Width 25 mm
On the market
rainbow block CADM01H
Genoss
CADM01H / CADM01H08809324767383
Width 25 mm
On the market
rainbow block CADM01L
Genoss
CADM01L / CADM01L08809324767369
Width 25 mm
On the market
rainbow block CADM03
Genoss
CADM03 / CADM0308809324767406
Width 44.5 mm
On the market
rainbow block CADM03H
Genoss
CADM03H / CADM03H08809324767413
Width 44.5 mm
On the market
rainbow block CADM03L
Genoss
CADM03L / CADM03L08809324767390
Width 44.5 mm
On the market
rainbow block CADM05
Genoss
CADM05 / CADM0508809324767437
Width 55.5 mm
On the market
rainbow block CADM05H
Genoss
CADM05H / CADM05H08809324767444
Width 55.5 mm
On the market
rainbow block CADM05L
Genoss
CADM05L / CADM05L08809324767420
Width 55.5 mm
On the market
rainbow block CADM07
Genoss
CADM07 / CADM0708809324767468
Width 63 mm
On the market
rainbow block CADM07H
Genoss
CADM07H / CADM07H08809324767475
Width 63 mm
On the market
rainbow block CADM07L
Genoss
CADM07L / CADM07L08809324767451
Width 63 mm
On the market
rainbow block CADM09
Genoss
CADM09 / CADM0908809324767499
Width 75.5 mm
On the market
rainbow block CADM09H
Genoss
CADM09H / CADM09H08809324767505
Width 75.5 mm
On the market
rainbow block CADM09L
Genoss
CADM09L / CADM09L08809324767482
Width 75.5 mm
On the market
rainbow block CADM12
Genoss
CADM12 / CADM1208809324767529
Width 89 mm
On the market
rainbow block CADM12H
Genoss
CADM12H / CADM12H08809324767536
Width 89 mm
On the market
rainbow block CADM12L
Genoss
CADM12L / CADM12L08809324767512
Width 89 mm
On the market
rainbow block CADM16
Genoss
CADM16 / CADM1608809324767550
Width 95 mm
On the market
rainbow block CADM16H
Genoss
CADM16H / CADM16H08809324767567
Width 95 mm
On the market
rainbow block CADM16L
Genoss
CADM16L / CADM16L08809324767543
Width 95 mm
On the market
rainbow block CADM9810
Genoss
CADM9810 / CADM981008809324765884
Outer Diameter 98 mm
On the market
rainbow block CADM9812
Genoss
CADM9812 / CADM981208809324765891
Outer Diameter 98 mm
On the market
rainbow block CADM9814
Genoss
CADM9814 / CADM981408809324765907
Outer Diameter 98 mm
On the market
rainbow block CADM9816
Genoss
CADM9816 / CADM981608809324765914
Outer Diameter 98 mm
On the market
rainbow block CADM9818
Genoss
CADM9818 / CADM981808809324765921
Outer Diameter 98 mm
On the market
rainbow block CADM9820
Genoss
CADM9820 / CADM982008809324765938
Outer Diameter 98 mm
On the market
rainbow block CADM9822
Genoss
CADM9822 / CADM982208809324765945
Outer Diameter 98 mm
On the market
rainbow block CADM9824
Genoss
CADM9824 / CADM982408809324765952
Outer Diameter 98 mm
On the market
rainbow Block W9812
Genoss
W9812 / W981208809324768380
Height 12 mm
On the market
rainbow Block W9814
Genoss
W9814 / W981408809324768397
Height 14 mm
On the market
rainbow Block W9816
Genoss
W9816 / W981608809324768403
Height 16 mm
On the market
rainbow Block W9818
Genoss
W9818 / W981808809324768410
Height 18 mm
On the market
rainbow Block W9820
Genoss
W9820 / W982008809324768427
Height 20 mm
On the market
rainbow Block W9822
Genoss
W9822 / W982208809324768434
Height 22 mm
On the market
rainbow Block W9824
Genoss
W9824 / W982408809324768441
Height 24 mm
On the market

Similar devices

Other devices filed under FDA product code EIH (Powder, Porcelain).

Other devices from GENOSS CO., Ltd.

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